Postoperative PainPhase 4NCT03570541
TQL-block for Laparoscopic Hemicolectomy
A Phase 4 study testing Ropivacaine, Acetaminophen and Morphine in people with Postoperative Pain, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Every year 350 patients undergo surgery due to colorectal cancer at Zealand University Hospital, Roskilde. The majority of the surgeries are performed using a minimal invasive laparoscopic technique where the bowl anastomosis is either hand sown or stapled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivacaine, Acetaminophen and Morphine
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Jun 2018to 3 Jan 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Scheduled for laparoscopic or robot assisted hemicolectomy or sigmoidectomy due to colon cancer
- Have received thorough information, oral and written, and signed the "Informed Consent" form on participation in the trial
- American Society of Anaesthesiologist physical status classification, class 1-3
Who cannot join
- Inability to cooperate
- Inability to speak and understand Danish
- Allergy to local anaesthetics or opioids
- Daily intake of opioids (evaluated by the investigators)
- Drug and/or substance abuse
- Local infection at the site of injection or systemic infection
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- Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
- Pregnant* or breastfeeding
- Daily use of oral or intravenous steroids
- Known immune deficiency (evaluated by the investigators)
- Other simultaneous or previous cancer diagnosis (except non-melanoma skin cancer) within the last five years (within the last five years added 28th nov 2019 after ethics committee approval).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Zealand University Hospital, Department of Anaesthesiology
Roskilde, 4000
About this study
Official title: Improving Perioperative Pain Management for Laparoscopic Surgery Due to Colon Cancer Using the Ultrasound-guided Transmuscular Quadratus Lumborum Block. A Double Blind, Randomized, Placebo Controlled Trial.
Every year 350 patients undergo surgery due to colorectal cancer at Zealand University Hospital, Roskilde. The majority of the surgeries are performed using a minimal invasive laparoscopic technique where the bowl anastomosis is either hand sown or stapled. The procedure is performed, while the patient is under general anaesthesia.
An observational prospective survey from 2016-17 of sixty patients undergoing hemicolectomy at Zealand University Hospital, Roskilde has shown, that even though the patients are subjected to a multimodal analgesic regimen, a substantial amount of opioids are being administered during the first 24 hours post surgery; i.e. 51.91 mg ± 36.22 mg (Mean ± SD) of oral morphine equivalents. Sixty-five percent of the patients receive opioids at the PACU. Their maximum pain score at the PACU is registered, using a numerical rating scale of 0-10, as 3.28 ± 2.65 (Mean ± SD). So it is obvious that there is room for improvement and a reduction in the use of postoperative opioids. Thus, there is a clearly defined research problem to explore.
Read more
Currently ultrasound-guided nerveblocks are not part of the multimodal analgesic regimen.
The primary aim of this study is to investigate the efficacy of the ultrasound-guided bilateral transmuscular quadratus lumborum block on reducing postoperative opioid consumption.
Read the detailed description
Every year 350 patients undergo surgery due to colorectal cancer at Zealand University Hospital, Roskilde. The vast majority of the patients has to have part of their colon removed, a so-called hemicolectomy. The majority of the surgeries are performed using a minimal invasive laparoscopic technique where the bowl anastomosis is either hand sown or stapled. The procedure is performed, while the patient is under general anaesthesia using a continuous intravenous (iv.) infusion of propofol and remifentanil to keep the patient asleep. As postoperative pain management the patients receive IV. paracetamol, IV. sufentanil (30 minutes prior to surgery) and local would infiltration.
At the post anaesthesia care unit (PACU) the patients are offered paracetamol and morphine as pain management. An observational prospective survey from 2016-17 of sixty patients undergoing hemicolectomy at Zealand University Hospital, Roskilde has shown, that even though the patients are subjected to a multimodal analgesic regimen as described, a substantial amount of opioids are being administered during the first 24 hours post surgery; i.e. 51.91 mg ± 36.22 mg (Mean ± SD) of oral morphine equivalents. Sixty-five percent of the patients receive opioids at the PACU. Their maximum pain score at the PACU is registered, using a numerical rating scale of 0-10, as 3.28 ± 2.65 (Mean ± SD). So it is obvious that there is room for improvement and a reduction in the use of postoperative opioids. Thus, there is a clearly defined research problem to explore.
Surgical technique:
The procedure is performed as a standard 4 port laparoscopic or robot-assisted technique with a vessel first dissection approach. The principles of complete mesocolic excision with is the standard procedure. The extraction site is for the right side and transverse colon through an upper transverse incision and for the left side and rectum through a pfannenstiel incision.
Anaesthesia and postoperative pain management:
The laparoscopic hemicolectomy is performed with the patient under general anaesthesia. As the surgery ends the surgeon injects local would infiltration in the laparoscopic port entries. Around 30 minutes prior to emergence the anaesthetic nurse injects iv. sufentanil (synthetic morphine), often around 0.3 μg/kg and 1g of iv. paracetamol. At the PACU a nurse will administer iv. morphine or sufentanil or oral morphine, when needed. The postoperative pain management continues at the surgical ward, where morphine is administered when needed. Paracetamol 1 gram x 4 daily is administered until discharge.
Side effects of current treatment:
The use of morphine can cause severe side effects, including nausea and vomiting, bowl paralysis, urine retention, sleep disturbances and respiratory depression. These side effects can delay mobilisation after surgery, increase the risk of complications and worst of all be fatal.
Recent research indicates a connection between immunologic and stress related reactions in relation to surgery and the development of cancer metastasis. It has already been shown, that a minimal invasive surgical technique, laparoscopic vs. open surgery, improves the postoperative immunologic response. A recent meta-analysis shows that perioperative regional anaesthesia/analgesia improves survival in cancer patients, which can be related to a reduction in metastasis due to a reduced surgical stress response. This indicates, that there are multiple advantages in offering an opioid sparing pain management, that also reduces the stress response related to surgery. The short term advantage being a reduction in postoperative opioid consumption, opioid-related side effects and postoperative pain score and possibly a long-term advantage of fewer cancer recurrences.
Ultrasound-guided nerve blocks:
With regards to the side effects related to the current treatment it has been of the upmost interest to develop new techniques to manage postoperative pain and a at the same time reduce surgical stress. Associate Professor and head of research at The Department of Anaesthesiology and Intensive Care, Jens Børglum, has in collaboration with other international peripheral nerve block experts developed several different abdominal nerve blocks that are described in both cadaveric and clinical randomized studies. Of specific interest to this study is the Transmuscular Quadratus Lumborum(TQL) block, an ultrasound-guided(USG) single-shot nerve block using local anaesthesia, designed to anaesthetize the entire abdominal wall and viscera and the retroperitoneal area. Using ultrasound as visual guidance provides extra safety and insurance of the correct placement of local anaesthetic. The TQL block is described in a recent cadaver study and in several peer review articles. There are two other clinical trials using the TQL-block for percutaneous nefro-lithotripsy and for caesarean section (Eudra-CT 2016-004594-41/2015-004770-16). Both of these trials have ended patient inclusion, and the preliminary data analysis have clearly showed a vast improvement in postoperative pain management and early mobilization with the active TQL blocks - without any adverse events recorded.
The pain from laparoscopic abdominal surgery arises from several locations, both the surgical incisions, the inflation of the entire abdominal wall and parietal peritoneum and traction/stress on the colon.
The innervation of the abdominal wall origins at the ventral rami of the spinal nerves from Th6-L1. The intercostal nerves (VII-XI) and the subcostal nerve all branch out in a lateral and anterior branch. The iliohypogastric and the ilioinguinal nerves innervate the lower part of the abdominal wall. The visceral pain arising from the intraperitoneal organs; i.e. colon, travel via different nerves to join in the thoracic sympathetic trunk before entering the central nervous system. The results from the cadaveric study show a very favourable spread of injectate with the TQL block. Not only does the injected dye in this study spread to colour the ventral rami of the thoracic spinal nerves up to T9 in the thoracic paravertebral space and the iliohypogastric and ilioinguinal nerve; the injectate also spread to colour the thoracic sympathetic trunk. Thus, this seem to indicate that the TQL block can be used to treat not only the pain from the incisions and tears superficially to the colon, but also the pain from the colon itself, and the adjacent intraperitoneal organs and structures, which is affected in patients undergoing laparoscopic hemicolectomy. The cadaveric study has also shown that the lumbar sympathetic trunk and lumbar plexus were not affected by the injected dye. These results seem to imply that there would be minimal or no affection of ambulation or lumbar sympathectomy; i.e. no hypotension or dysfunctional bladder as can often be observed with the epidural technique. Both findings that coincides with the clinical experiences from the investigators pilot studies, and indeed also from the aforementioned clinical trials that have just been finalized.
Cancer progression and the peroperative immunologic stress response:
Studies suggest that events in the perioperative period can induce metastasis formation and tumor growth. Tumor cells are released into the blood stream during surgery and the surgical stress may create a favorable environment for dissemination of tumor cells into distant tissue. This is done by a cascade of pro-cancerous catecholamines, prostaglandins and cytokines combined with an impaired anti-cancerous cell mediated immune response.
Until recently, focus on the anesthetic management of cancer patients has been limited. Relatively small alterations in the perioperative anesthetic management may play a tremendous role in tumor progression. Optimizing anesthesia to reduce the surgical stress response could improve recurrence rates and long-term outcomes for cancer patients by inhibiting perioperative metastasis formation. Regional anesthesia and amide local anesthetics are suspected to calm the immunologic storm of prostaglandins, catecholamines and cytokines when used in the perioperative phase.
Aim: The investigators want to help create an opioid sparing anaesthesia, thus reducing opioid related side effects.
Therefore, the investigators wish to conduct a randomized, controlled and double blind study, comparing the effect of the TQL-block vs. placebo. The aim with this study is to investigate the efficacy of the TQL block vs. placebo in patients undergoing laparoscopic surgery due to colon cancer.
The hypothesis is, that the bilateral TQL block will significantly reduce the opioid consumption during the first 24 postoperative hours and significantly reduce the Numerical Rating Scale (NRS) pain score (0-10) and opioid related side effects.
The investigators will further obtain blood samples in the perioperative period in order to demonstrate effects on the immune system between the two groups. Blood samples and heart rate variability measurement results will be reported in separate peer-review publications.
- Conditions
- Postoperative Pain
- Being tested
- Ropivacaine, Acetaminophen, Patient controlled analgesia, Morphine, Saline
- Keywords
- Colon cancer, nerve block, ultra-sound, opioids, surgical stress
- Medical subject headings
- Pain, Postoperative, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
30 mL ropivacaine 0,375% administered on each side as bilateral TQL blocks
AcetaminophenDrug
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
Patient controlled analgesiaDevice
PCA-pump with IV-Morphine. 5 mg administered per bolus. Lock-out time and max. dosage standardized.
MorphineDrug
intravenously administered morphine via PCA-pump
SalineDrug
30 ml saline 0,375% administered on each side as bilateral TQL blocks
Blood samplesDiagnostic test
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis
Quality of recovery-15 questionaireBehavioural
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a short questionaire.
Orthostatic hypotensionDiagnostic test
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0,375% single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension. Receives: Drug: Ropivacaine; Drug: Acetaminophen; Device: Patient controlled analgesia; Drug: Morphine; Diagnostic Test: Blood samples; Behavioral: Quality of recovery-15 questionaire; Diagnostic Test: Orthostatic hypotension |
| Placebo | Placebo comparator | Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL saline single shot.
Every six hours postoperative, all patients are administered 1 g of acetaminophen.
In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.
On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis.
On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire.
Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension. Receives: Drug: Acetaminophen; Device: Patient controlled analgesia; Drug: Morphine; Drug: Saline; Diagnostic Test: Blood samples; Behavioral: Quality of recovery-15 questionaire; Diagnostic Test: Orthostatic hypotension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Data from PCA pump and patient medical record
Measured: Twenty-four hours postoperative
Secondary outcomes (38)
Pain during mobilisation
(Numerical rating scale 0-10/10). No pain = 0, worst pain = 10.
Measured: Registered upon arrival at the postanaesthesia care unit (PACU) and again 30 min, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 hours postoperative.
Pain at rest
(Numerical rating scale 0-10/10). No pain = 0, worst pain = 10.
Measured: Registered upon arrival at the PACU and again 30 min, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 hours postoperative.
An integrated assessment of longitudinally measured pain intensity and opioid consumption
This assessment is calculated using data from outcome 1 and 2. An individual rank for pain intensity using numerical rating scale (0-10/10), 0-24 hours postoperatively and for total opioid consumption 0-24 hours postoperatively will be combined and compared with a mean rank of all patients (active and placebo). The difference between the individual rank and the mean rank will be expressed as a percentage.
As described by: Andersen LPK, Gögenur I, Torup H, Rosenberg J, Werner MU. Assessment of Postoperative Analgesic Drug Efficacy: Method of Data Analysis Is Critical. Anesth Analg. 2017 Sep;125(3):1008-13.
Measured: 0-24 hours postoperative
Morphine consumption
Data from PCA pump and patient medical record
Measured: At 6, 12, 18 postoperative hours.
Duration of block
How long does the TQL block work
Measured: Time to first opioid within the first 24 postoperative hours
The degree of morphine-related side effects. Nausea or post anaesthesia nausea and vomiting (PONV) registered in the case report form, if any.
PONV 0-3; 0=No nausea. 3=Unmanageable nausea
Measured: 24 hours postoperative
Pain upon ambulation (walking 5 meters with aid)
Evaluated using Numerical rating scale (0-10/10). No pain = 0, worst pain = 10.
Measured: At 3, 6 and 24 hours postoperative
Orthostatic hypotension (yes/no) and orthostatic intolerance i.e. symptoms of orthostatic hypotension without a drop in blood pressure (yes/no).
Evaluated using standardised test regularly used at the Department of Surgery
Measured: Before surgery and at 3, 6 and 24 hours postoperative
Quality of Recovery - 15 questionnaire
The Quality of Recovery -15 questionnaire results in a score of 0-150. Very poor recovery = 0, excellent recovery = 150. These outcome measures will be correlated with changes in immunologic outcome measures in the perioperative period.
Measured: Preoperatively and day 1+2 and 10-14 post surgery
Surgical complications
Classified using the Clavien-Dindo classification
Measured: 30 days post surgery
Time to discharge
Data from the patient medical record
Measured: 30 days after surgery
Heart Rate Variability (HRV)
On 24 consecutive patients (3 randomization blocks of 4) data will be obtained on heart rate variability using electrocardiography from block administration and the first 24 hours postoperatively. Minimal changes in HRV characterizes differences in sympathetic stress response between the groups
Measured: From block administration and to 24 hours postoperative
Whole blood gene expression profiling
An evaluation of gene expression fold changes compared to POD 0 using an Affymetrix gene expression array. The investigators will specifically measure relative changes in expression of the GZMB gene, which encodes Granzyme B. Granzyme B is expressed by cytotoxic t-cells and NK-cells. The regularized t-test limma will be used to calculate differences in gene expression between samples taken at different time sets, and the Benjamini Hochberg method using the false discovery rate (FDR) will be used to correct for multiple hypothesis testing.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
tumor necrosis factor alpha
Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to postoperative day (POD) 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-1b
Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin -2
Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-6
Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-8
Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-10
Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-11
Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-15
Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-17a
Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-17f
Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-18
Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-22
Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Granulocyte-macrophage colony-stimulating factor
Part of cytokine assays for alterations in inflammation and cancer related immune-function measured by commercial enzyme-linked immunosorbent assays (ELISAs) on a BEP2000 ELISA instrument. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Hemoglobin
Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Leucocytes including differential count
Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Thrombocytes
Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Alanine aminotransferase (ALAT)
Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Lactate dehydrogenase
Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Bilirubin
Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Prothrombin time (International normalized ratio)
Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Albumin
Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Sodium
Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Potassium
Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
C reactive Protein
Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Glucose
Part of standard blood samples that will be obtained and analyzed immediately at each time point. Relative changes compared to POD 0.
Measured: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start28 Jun 2018
- Primary completion5 Dec 2020
- Study completion3 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katrine Tanggaard, MD, Principal investigator, Department of Anaesthesiology, Zealand University Hospital, Roskilde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570541
- Sponsor's protocol ID
- SJ-663
- Other IDs
- 2017-005200-96, 2017
- Status last verified
- Jan 2021
- First submitted
- 15 May 2018
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Årsrapporter [Internet]. [cited 2017 Jun 7]. Available from: http://www.dccg.dk/03_Publikation/02_arsraport.html
Kehlet H. Postoperative opioid sparing to hasten recovery: what are the issues? Anesthesiology. 2005 Jun;102(6):1083-5. doi: 10.1097/00000542-200506000-00004. No abstract available.
PubMed 15915017Sondergaard ES, Gogenur I. [Oxidative stress may cause metastatic disease in patients with colorectal cancer]. Ugeskr Laeger. 2015 Apr 27;177(18):857-60. Danish.
PubMed 26539573Gogenur M, Watt SK, Gogenur I. [Improved immunologic response after laparoscopic versus open colorectal cancer surgery]. Ugeskr Laeger. 2015 Jul 13;177(29):V12140763. Danish.
PubMed 26239962Sun Y, Li T, Gan TJ. The Effects of Perioperative Regional Anesthesia and Analgesia on Cancer Recurrence and Survival After Oncology Surgery: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):589-98. doi: 10.1097/AAP.0000000000000273.
PubMed 26263074Borglum J, Jensen K, Christensen AF, Hoegberg LC, Johansen SS, Lonnqvist PA, Jansen T. Distribution patterns, dermatomal anesthesia, and ropivacaine serum concentrations after bilateral dual transversus abdominis plane block. Reg Anesth Pain Med. 2012 May-Jun;37(3):294-301. doi: 10.1097/AAP.0b013e31824c20a9.
PubMed 22476239Borglum J, Maschmann C, Belhage B, Jensen K. Ultrasound-guided bilateral dual transversus abdominis plane block: a new four-point approach. Acta Anaesthesiol Scand. 2011 Jul;55(6):658-63. doi: 10.1111/j.1399-6576.2011.02430.x. Epub 2011 Apr 4.
PubMed 21463262Jensen K, Baek N, Jensen JT, Brglum J. Bilateral dual transversus abdominis plane block providing surgical anaesthesia for abdominal wall surgery. Anaesthesia. 2013 Jan;68(1):106-8. doi: 10.1111/anae.12103. No abstract available.
PubMed 23231609Petersen M, Elers J, Borglum J, Belhage B, Mortensen J, Maschmann C. Is pulmonary function affected by bilateral dual transversus abdominis plane block? A randomized, placebo-controlled, double-blind, crossover pilot study in healthy male volunteers. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):568-71. doi: 10.1097/AAP.0b013e3182330b95.
PubMed 22005660Baerentzen F, Maschmann C, Jensen K, Belhage B, Hensler M, Borglum J. Ultrasound-guided nerve block for inguinal hernia repair: a randomized, controlled, double-blind study. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):502-7. doi: 10.1097/AAP.0b013e31825a3c8a.
PubMed 22705951Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378.
PubMed 27429253Tanggaard K, Jensen K, Lenz K, Vazin M, Binzer J, Lindberg-Larsen VO, Niegsch M, Bendtsen TF, Jorgensen LN, Borglum J. A randomised controlled trial of bilateral dual transversus abdominis plane blockade for laparoscopic appendicectomy. Anaesthesia. 2015 Dec;70(12):1395-400. doi: 10.1111/anae.13234. Epub 2015 Oct 14.
PubMed 26464041Børglum J, Moriggl B, Jensen K, Lønnqvist P-A, Christensen AF, Sauter A, et al. Ultrasound-Guided Transmuscular Quadratus Lumborum Blockade. Br J Anaesth [Internet]. 2013 Apr 22 [cited 2017 May 29];111(eLetters Supplement). Available from: https://academic.oup.com/bja/article/doi/10.1093/bja/el_9919/2451466/Ultrasound-Guided-Transmuscular-Quadratus-Lumborum
Dam M, Hansen CK, Borglum J, Chan V, Bendtsen TF. A transverse oblique approach to the transmuscular Quadratus Lumborum block. Anaesthesia. 2016 May;71(5):603-4. doi: 10.1111/anae.13453. No abstract available.
PubMed 27072772Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Borglum J. The Pathway of Injectate Spread With the Transmuscular Quadratus Lumborum Block: A Cadaver Study. Anesth Analg. 2017 Jul;125(1):303-312. doi: 10.1213/ANE.0000000000001922.
PubMed 28277325
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Perioperative Pain Management for Laparoscopic Surgery Due to Colon Cancer Using the Ultrasound-guided Transmuscular Quadratus Lumborum Block. A Double Blind, Randomized, Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT03570541
- Acronym / sponsor ID
- SJ-663
- Conditions
- Postoperative Pain
- Keywords
- Colon cancer, nerve block, ultra-sound, opioids, surgical stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 5 Dec 2020 (actual)
- Study completion
- 3 Jan 2021 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Every year 350 patients undergo surgery due to colorectal cancer at Zealand University Hospital, Roskilde. The majority of the surgeries are performed using a minimal invasive laparoscopic technique where the bowl anastomosis is either hand sown or stapled. The procedure is performed, while the patient is under general anaesthesia.
An observational prospective survey from 2016-17 of sixty patients undergoing hemicolectomy at Zealand University Hospital, Roskilde has shown, that even though the patients are subjected to a multimodal analgesic regimen, a substantial amount of opioids are being administered during the first 24 hours post surgery; i.e. 51.91 mg ± 36.22 mg (Mean ± SD) of oral morphine equivalents. Sixty-five percent of the patients receive opioids at the PACU. Their maximum pain score at the PACU is registered, using a numerical rating scale of 0-10, as 3.28 ± 2.65 (Mean ± SD). So it is obvious that there is room for improvement and a reduction in the use of postoperative opioids. Thus, there is a clearly defined research problem to explore.
Currently ultrasound-guided nerveblocks are not part of the multimodal analgesic regimen.
The primary aim of this study is to investigate the efficacy of the ultrasound-guided bilateral transmuscular quadratus lumborum block on reducing postoperative opioid consumption.
Detailed description
Every year 350 patients undergo surgery due to colorectal cancer at Zealand University Hospital, Roskilde. The vast majority of the patients has to have part of their colon removed, a so-called hemicolectomy. The majority of the surgeries are performed using a minimal invasive laparoscopic technique where the bowl anastomosis is either hand sown or stapled. The procedure is performed, while the patient is under general anaesthesia using a continuous intravenous (iv.) infusion of propofol and remifentanil to keep the patient asleep. As postoperative pain management the patients receive IV. paracetamol, IV. sufentanil (30 minutes prior to surgery) and local would infiltration.
At the post anaesthesia care unit (PACU) the patients are offered paracetamol and morphine as pain management. An observational prospective survey from 2016-17 of sixty patients undergoing hemicolectomy at Zealand University Hospital, Roskilde has shown, that even though the patients are subjected to a multimodal analgesic regimen as described, a substantial amount of opioids are being administered during the first 24 hours post surgery; i.e. 51.91 mg ± 36.22 mg (Mean ± SD) of oral morphine equivalents. Sixty-five percent of the patients receive opioids at the PACU. Their maximum pain score at the PACU is registered, using a numerical rating scale of 0-10, as 3.28 ± 2.65 (Mean ± SD). So it is obvious that there is room for improvement and a reduction in the use of postoperative opioids. Thus, there is a clearly defined research problem to explore.
Surgical technique:
The procedure is performed as a standard 4 port laparoscopic or robot-assisted technique with a vessel first dissection approach. The principles of complete mesocolic excision with is the standard procedure. The extraction site is for the right side and transverse colon through an upper transverse incision and for the left side and rectum through a pfannenstiel incision.
Anaesthesia and postoperative pain management:
The laparoscopic hemicolectomy is performed with the patient under general anaesthesia. As the surgery ends the surgeon injects local would infiltration in the laparoscopic port entries. Around 30 minutes prior to emergence the anaesthetic nurse injects iv. sufentanil (synthetic morphine), often around 0.3 μg/kg and 1g of iv. paracetamol. At the PACU a nurse will administer iv. morphine or sufentanil or oral morphine, when needed. The postoperative pain management continues at the surgical ward, where morphine is administered when needed. Paracetamol 1 gram x 4 daily is administered until discharge.
Side effects of current treatment:
The use of morphine can cause severe side effects, including nausea and vomiting, bowl paralysis, urine retention, sleep disturbances and respiratory depression. These side effects can delay mobilisation after surgery, increase the risk of complications and worst of all be fatal.
Recent research indicates a connection between immunologic and stress related reactions in relation to surgery and the development of cancer metastasis. It has already been shown, that a minimal invasive surgical technique, laparoscopic vs. open surgery, improves the postoperative immunologic response. A recent meta-analysis shows that perioperative regional anaesthesia/analgesia improves survival in cancer patients, which can be related to a reduction in metastasis due to a reduced surgical stress response. This indicates, that there are multiple advantages in offering an opioid sparing pain management, that also reduces the stress response related to surgery. The short term advantage being a reduction in postoperative opioid consumption, opioid-related side effects and postoperative pain score and possibly a long-term advantage of fewer cancer recurrences.
Ultrasound-guided nerve blocks:
With regards to the side effects related to the current treatment it has been of the upmost interest to develop new techniques to manage postoperative pain and a at the same time reduce surgical stress. Associate Professor and head of research at The Department of Anaesthesiology and Intensive Care, Jens Børglum, has in collaboration with other international peripheral nerve block experts developed several different abdominal nerve blocks that are described in both cadaveric and clinical randomized studies. Of specific interest to this study is the Transmuscular Quadratus Lumborum(TQL) block, an ultrasound-guided(USG) single-shot nerve block using local anaesthesia, designed to anaesthetize the entire abdominal wall and viscera and the retroperitoneal area. Using ultrasound as visual guidance provides extra safety and insurance of the correct placement of local anaesthetic. The TQL block is described in a recent cadaver study and in several peer review articles. There are two other clinical trials using the TQL-block for percutaneous nefro-lithotripsy and for caesarean section (Eudra-CT 2016-004594-41/2015-004770-16). Both of these trials have ended patient inclusion, and the preliminary data analysis have clearly showed a vast improvement in postoperative pain management and early mobilization with the active TQL blocks - without any adverse events recorded.
The pain from laparoscopic abdominal surgery arises from several locations, both the surgical incisions, the inflation of the entire abdominal wall and parietal peritoneum and traction/stress on the colon.
The innervation of the abdominal wall origins at the ventral rami of the spinal nerves from Th6-L1. The intercostal nerves (VII-XI) and the subcostal nerve all branch out in a lateral and anterior branch. The iliohypogastric and the ilioinguinal nerves innervate the lower part of the abdominal wall. The visceral pain arising from the intraperitoneal organs; i.e. colon, travel via different nerves to join in the thoracic sympathetic trunk before entering the central nervous system. The results from the cadaveric study show a very favourable spread of injectate with the TQL block. Not only does the injected dye in this study spread to colour the ventral rami of the thoracic spinal nerves up to T9 in the thoracic paravertebral space and the iliohypogastric and ilioinguinal nerve; the injectate also spread to colour the thoracic sympathetic trunk. Thus, this seem to indicate that the TQL block can be used to treat not only the pain from the incisions and tears superficially to the colon, but also the pain from the colon itself, and the adjacent intraperitoneal organs and structures, which is affected in patients undergoing laparoscopic hemicolectomy. The cadaveric study has also shown that the lumbar sympathetic trunk and lumbar plexus were not affected by the injected dye. These results seem to imply that there would be minimal or no affection of ambulation or lumbar sympathectomy; i.e. no hypotension or dysfunctional bladder as can often be observed with the epidural technique. Both findings that coincides with the clinical experiences from the investigators pilot studies, and indeed also from the aforementioned clinical trials that have just been finalized.
Cancer progression and the peroperative immunologic stress response:
Studies suggest that events in the perioperative period can induce metastasis formation and tumor growth. Tumor cells are released into the blood stream during surgery and the surgical stress may create a favorable environment for dissemination of tumor cells into distant tissue. This is done by a cascade of pro-cancerous catecholamines, prostaglandins and cytokines combined with an impaired anti-cancerous cell mediated immune response.
Until recently, focus on the anesthetic management of cancer patients has been limited. Relatively small alterations in the perioperative anesthetic management may play a tremendous role in tumor progression. Optimizing anesthesia to reduce the surgical stress response could improve recurrence rates and long-term outcomes for cancer patients by inhibiting perioperative metastasis formation. Regional anesthesia and amide local anesthetics are suspected to calm the immunologic storm of prostaglandins, catecholamines and cytokines when used in the perioperative phase.
Aim: The investigators want to help create an opioid sparing anaesthesia, thus reducing opioid related side effects.
Therefore, the investigators wish to conduct a randomized, controlled and double blind study, comparing the effect of the TQL-block vs. placebo. The aim with this study is to investigate the efficacy of the TQL block vs. placebo in patients undergoing laparoscopic surgery due to colon cancer.
The hypothesis is, that the bilateral TQL block will significantly reduce the opioid consumption during the first 24 postoperative hours and significantly reduce the Numerical Rating Scale (NRS) pain score (0-10) and opioid related side effects.
The investigators will further obtain blood samples in the perioperative period in order to demonstrate effects on the immune system between the two groups. Blood samples and heart rate variability measurement results will be reported in separate peer-review publications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: Ropivacaine, Drug: Acetaminophen, Device: Patient controlled analgesia, Drug: Morphine, Diagnostic Test: Blood samples, Behavioral: Quality of recovery-15 questionaire, Diagnostic Test: Orthostatic hypotensionActive bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL ropivacaine 0,375% single shot. Every six hours postoperative, all patients are administered 1 g of acetaminophen. In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment. On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis. On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire. Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension. |
| Placebo | Placebo comparator | Drug: Acetaminophen, Device: Patient controlled analgesia, Drug: Morphine, Drug: Saline, Diagnostic Test: Blood samples, Behavioral: Quality of recovery-15 questionaire, Diagnostic Test: Orthostatic hypotensionPlacebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 mL saline single shot. Every six hours postoperative, all patients are administered 1 g of acetaminophen. In both arms morphine will be administered IV as part of a patient controlled analgesia (PCA)-pump regimen or additionally after contact with the nursing staff as it is the standard treatment. On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis. On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a Quality of recovery-15 questionaire. Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18
- Scheduled for laparoscopic or robot assisted hemicolectomy or sigmoidectomy due to colon cancer
- Have received thorough information, oral and written, and signed the "Informed Consent" form on participation in the trial
- American Society of Anaesthesiologist physical status classification, class 1-3
Key exclusion criteria (11 listed)
- Inability to cooperate
- Inability to speak and understand Danish
- Allergy to local anaesthetics or opioids
- Daily intake of opioids (evaluated by the investigators)
- Drug and/or substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine30 mL ropivacaine 0,375% administered on each side as bilateral TQL blocks | Drug | Active |
| AcetaminophenEvery six hours postoperative, all patients are administered 1 g of acetaminophen. | Drug | Active, Placebo |
| Patient controlled analgesiaPCA-pump with IV-Morphine. 5 mg administered per bolus. Lock-out time and max. dosage standardized. | Device | Active, Placebo |
| Morphineintravenously administered morphine via PCA-pump | Drug | Active, Placebo |
| Saline30 ml saline 0,375% administered on each side as bilateral TQL blocks | Drug | Placebo |
| Blood samplesOn the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis | Diagnostic test | Active, Placebo |
| Quality of recovery-15 questionaireOn the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a short questionaire. | Behavioural | Active, Placebo |
| Orthostatic hypotensionBefore surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension. | Diagnostic test | Active, Placebo |
Primary outcome
Total morphine consumption
Time frame: Twenty-four hours postoperative
Data from PCA pump and patient medical record
38 secondary outcomes
Pain during mobilisation
Time frame: Registered upon arrival at the postanaesthesia care unit (PACU) and again 30 min, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 hours postoperative.
Pain at rest
Time frame: Registered upon arrival at the PACU and again 30 min, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 hours postoperative.
An integrated assessment of longitudinally measured pain intensity and opioid consumption
Time frame: 0-24 hours postoperative
Morphine consumption
Time frame: At 6, 12, 18 postoperative hours.
Duration of block
Time frame: Time to first opioid within the first 24 postoperative hours
The degree of morphine-related side effects. Nausea or post anaesthesia nausea and vomiting (PONV) registered in the case report form, if any.
Time frame: 24 hours postoperative
Pain upon ambulation (walking 5 meters with aid)
Time frame: At 3, 6 and 24 hours postoperative
Orthostatic hypotension (yes/no) and orthostatic intolerance i.e. symptoms of orthostatic hypotension without a drop in blood pressure (yes/no).
Time frame: Before surgery and at 3, 6 and 24 hours postoperative
Quality of Recovery - 15 questionnaire
Time frame: Preoperatively and day 1+2 and 10-14 post surgery
Surgical complications
Time frame: 30 days post surgery
Time to discharge
Time frame: 30 days after surgery
Heart Rate Variability (HRV)
Time frame: From block administration and to 24 hours postoperative
Whole blood gene expression profiling
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
tumor necrosis factor alpha
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-1b
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin -2
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-6
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-8
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-10
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-11
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-15
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-17a
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-17f
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-18
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
interleukin-22
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Granulocyte-macrophage colony-stimulating factor
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Hemoglobin
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Leucocytes including differential count
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Thrombocytes
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Alanine aminotransferase (ALAT)
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Lactate dehydrogenase
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Bilirubin
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Prothrombin time (International normalized ratio)
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Albumin
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Sodium
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Potassium
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
C reactive Protein
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Glucose
Time frame: Blood samples are taken preoperatively, day 1+2 and 10-14 post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- BackgroundÅrsrapporter [Internet]. [cited 2017 Jun 7]. Available from: http://www.dccg.dk/03_Publikation/02_arsraport.html
- Background: PubMed 15915017Kehlet H. Postoperative opioid sparing to hasten recovery: what are the issues? Anesthesiology. 2005 Jun;102(6):1083-5. doi: 10.1097/00000542-200506000-00004. No abstract available.
- Background: PubMed 26539573Sondergaard ES, Gogenur I. [Oxidative stress may cause metastatic disease in patients with colorectal cancer]. Ugeskr Laeger. 2015 Apr 27;177(18):857-60. Danish.
- Background: PubMed 26239962Gogenur M, Watt SK, Gogenur I. [Improved immunologic response after laparoscopic versus open colorectal cancer surgery]. Ugeskr Laeger. 2015 Jul 13;177(29):V12140763. Danish.
- Background: PubMed 26263074Sun Y, Li T, Gan TJ. The Effects of Perioperative Regional Anesthesia and Analgesia on Cancer Recurrence and Survival After Oncology Surgery: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):589-98. doi: 10.1097/AAP.0000000000000273.
- Background: PubMed 22476239Borglum J, Jensen K, Christensen AF, Hoegberg LC, Johansen SS, Lonnqvist PA, Jansen T. Distribution patterns, dermatomal anesthesia, and ropivacaine serum concentrations after bilateral dual transversus abdominis plane block. Reg Anesth Pain Med. 2012 May-Jun;37(3):294-301. doi: 10.1097/AAP.0b013e31824c20a9.
- Background: PubMed 21463262Borglum J, Maschmann C, Belhage B, Jensen K. Ultrasound-guided bilateral dual transversus abdominis plane block: a new four-point approach. Acta Anaesthesiol Scand. 2011 Jul;55(6):658-63. doi: 10.1111/j.1399-6576.2011.02430.x. Epub 2011 Apr 4.
- Background: PubMed 23231609Jensen K, Baek N, Jensen JT, Brglum J. Bilateral dual transversus abdominis plane block providing surgical anaesthesia for abdominal wall surgery. Anaesthesia. 2013 Jan;68(1):106-8. doi: 10.1111/anae.12103. No abstract available.
- Background: PubMed 22005660Petersen M, Elers J, Borglum J, Belhage B, Mortensen J, Maschmann C. Is pulmonary function affected by bilateral dual transversus abdominis plane block? A randomized, placebo-controlled, double-blind, crossover pilot study in healthy male volunteers. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):568-71. doi: 10.1097/AAP.0b013e3182330b95.
- Background: PubMed 22705951Baerentzen F, Maschmann C, Jensen K, Belhage B, Hensler M, Borglum J. Ultrasound-guided nerve block for inguinal hernia repair: a randomized, controlled, double-blind study. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):502-7. doi: 10.1097/AAP.0b013e31825a3c8a.
- Background: PubMed 27429253Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378.
- Background: PubMed 26464041Tanggaard K, Jensen K, Lenz K, Vazin M, Binzer J, Lindberg-Larsen VO, Niegsch M, Bendtsen TF, Jorgensen LN, Borglum J. A randomised controlled trial of bilateral dual transversus abdominis plane blockade for laparoscopic appendicectomy. Anaesthesia. 2015 Dec;70(12):1395-400. doi: 10.1111/anae.13234. Epub 2015 Oct 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrine Tanggaard, MD principal investigator
Department of Anaesthesiology, Zealand University Hospital, Roskilde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine, Acetaminophen and Morphine in people with Postoperative Pain, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: Twenty-four hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03570541, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.