Colon NeoplasmNCT03458689
Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Patients Undergoing Left Hemicolectomy
A study testing Left hemicolectomy, laparoscopic technique in people with Colon Neoplasm and Surgery, run by Ostfold Hospital Trust at 1 site in Norway.
Trial summary
The enhanced recovery after surgery and laparoscopic approach have been proven beneficial in surgery of the colon. However, patients have still pain, nausea and vomiting postoperatively. Postoperative pain is an expected but undesirable effect after an operation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Neoplasm, Surgery, Pain, Postoperative
- What is being tested?
- Left hemicolectomy, laparoscopic technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNorway
- Study dates
- 28 Feb 2018to 31 Dec 2020
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 Years
- BMI 20-35
- ASA physical status I-II
Who cannot join
- Allergy to LA
- Chronic pain requiring opioid analgesics
- Patients with atrioventricular block II
- Patients treated with class III antiarrhythmics
- Patients with severe renal and/or hepatic disease
- A coagulation disorder
- An infection at the LA injection place
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Ostfold Hospital Trust, Moss
Grålum, Østfold fylke, 1714
Jan Sverre Vamnes, MD, Ph.D., +47 91608896, janvam@so-hf.no
Knut Inge Solbakk, md, +47 90933106, knisol@so-hf.no
About this study
Official title: Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Patients Undergoing Left Hemicolectomy: A Randomized Controlled Trial
The enhanced recovery after surgery and laparoscopic approach have been proven beneficial in surgery of the colon. However, patients have still pain, nausea and vomiting postoperatively. Postoperative pain is an expected but undesirable effect after an operation. This study will compare Transabdominis Plane (TAP) Block and Quadratus Lumborum (QL) Block with the common postoperative treatment with enteral and parenteral analgesics.
Read the detailed description
TAP is a recommended multimodal method of reducing postoperative pain in laparoscopic and open surgery. TAP block seems to be feasible and effective in postoperative pain control without increasing morbidity in colon resections. QL block is also performed as one of the perioperative pain management procedures in abdominal surgery. It is regarded as an effective analgesic tool. The dermatomal effects of QL block reach higher than the TAP block, and might explain the better effect of the QL block than TAP blocks on postoperative pain after caesarean delivery. For this study the investigators standardize the type of surgery to be left hemicolectomy. This is the most common procedure on colon.
Power and Sample Size Calculator:
The number of patients required for the study was calculated on the basis of opioid consumption. We were interested in a reduction by 20% in the group given QLB. Assuming α=0,05, we calculated that we need 69 patients (23 in each group) to achieve a power of 80% (β=0.2).
75 adult patients scheduled for left hemicolectomy have to be included.
Subcutaneous wound infiltration at the end of surgery in all patients with ropivacaine 2 mg/ml, 20 ml. Maximum allowed dosis of Ropivacain is 3 mg/kg bodyweight (BW), dosis reduction if BW<70 kg Premedication: Paracetamol 2 g and Diklofenak 100 mg orally. General anaesthesia: TCI: Propofol and Remifentanil Ondansetron 4 mg, dexamethasone 8 mg and Oxycodone 5 mg intravenously at the end of surgery.
Postoperatively:
Oral paracetamol and codeine-fixed combination up to 1000 mg and 60 mg, respectively, every 6 h In case of insufficient analgesia, as judged by the patient, oxycodon 2 - 5 mg IV.
When nausea and vomiting occure postoperatively, ondansetron 4 mg IV administers as the drug of first choice followed by droperidol 0,625 mg IV if the nausea/vomiting persists.
Collected data:
Postoperative pain at rest and during activity evaluated by a 4-points verbal pain score (VPS; with no pain=0, slight pain = 1, Moderate pain = 2, and severe pain = 3) on admission to recovery, and every hour until discharge.
Rescue analgesic consumption during 0 to 4, 4 to 24 and 24 to 48 h. Sedation, nausea and vomiting record by the same 0 - 3 scale (none, slight, moderate, strong) during recovery Time of postoperative mobilization with corresponding pain score. Time of discharge-to-home or ward readiness according to standard criteria, including stable vital signs, no bleeding from the surgical site, ability to void, absence of excessive nausea and pain, and ability to dress and walk without support.
Side effects including nausea and/or vomiting (0 to 4, 4 to 24, and 24 to 48 h), antiemetics administered (0 to 24 and 24 to 48 H), grade of sedation (0 to 10 scale, where 0 = awake, and 10 = aroused on stimulation), and other side effects and symptoms of LA toxicity.
Telephone interview at 24 h, 48 h and 7 days, with questions:
Pain during rest and activity using the VPS Total need of analgesics Sedation Nausea Level of activity Overall satisfaction with the per- and postoperative period on a 0 - 3 scale: not satisfied, slight, moderate or highly satisfied.
- Conditions
- Colon Neoplasm, Surgery, Pain, Postoperative
- Being tested
- Left hemicolectomy, laparoscopic technique
- Medical subject headings
- Colonic Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left hemicolectomy, laparoscopic techniqueProcedure or surgery
Also called QL block bilateral with ropivacain 3,75 mg/ml (2 x 20 ml), TAP block with ropivacain 3,75 mg/ml (2 x 20 ml), Traditional analgesics such as paracetamol and oksycodon
Left hemicolectomy, Laparoscopic technique
| Study group | Role | What they receive |
|---|---|---|
| Left hemicolectomy without nerve blocks | Other | Left hemicolectomy, laparoscopic technique Enteral and parenteral analgesics such as paracetamol and oksykodon Receives: Procedure: Left hemicolectomy, laparoscopic technique |
| Left hemicolectomy with TAP block | Active comparator | Left hemicolectomy, laparoscopic technique TAP block bilateral with Naropin 3,75 mg/ml, 2 x 20 ml Receives: Procedure: Left hemicolectomy, laparoscopic technique |
| Left hemicolectomy with QL block | Active comparator | Left hemicolectomy, laparoscopic technique QL block bilateral with Naropin 3,75 mg/ml, 2 x 20 ml Receives: Procedure: Left hemicolectomy, laparoscopic technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of analgesics - "change" is being assessed
Amount of analgesics used postoperative
Measured: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Secondary outcomes (6)
Pain at the incision site - "change" is being assessed
VPS (Verbal Pain Score): No pain = 0, Slight pain = 1, Moderate pain= 2, Severe pain = 3
Measured: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Deep pain and pain on coughing - "change" is being assessed
VPS (Verbal Pain Score): No pain = 0, Slight pain = 1, Moderate pain= 2, Severe pain = 3
Measured: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed
Amount of different medicaments in mg
Measured: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Postoperative nausea and vomiting - "change" is being assessed
0 - 3 score where None = 0, Little nausea = 1, Can not eat = 2, Vomiting = 3
Measured: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Antiemetic administered - "change" is being assessed
Amount of different medicaments in mg
Measured: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Sedation scores - "change" is being assessed
Sleepy or active. Score: Awake = 0, Tired = 1, Falls asleep = 2, Asleep all the time = 3
Measured: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start28 Feb 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colon NeoplasmStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Sverre Vamnes, Ostfold Hospital Trust
- Investigators
- Jan Sverre Vamnes, MD, Ph.D., Principal investigator, Senior Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458689
- Sponsor's protocol ID
- 1813
- Status last verified
- Mar 2019
- First submitted
- 28 Feb 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borglum 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 27429253Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
PubMed 27755488El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.
PubMed 19376789Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.
PubMed 26735154Pirrera B, Alagna V, Lucchi A, Berti P, Gabbianelli C, Martorelli G, Mozzoni L, Ruggeri F, Ingardia A, Nardi G, Garulli G. Transversus abdominis plane (TAP) block versus thoracic epidural analgesia (TEA) in laparoscopic colon surgery in the ERAS program. Surg Endosc. 2018 Jan;32(1):376-382. doi: 10.1007/s00464-017-5686-7. Epub 2017 Jul 1.
PubMed 28667547Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
PubMed 28154824
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Patients Undergoing Left Hemicolectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03458689
- Acronym / sponsor ID
- 1813
- Conditions
- Colon Neoplasm, Surgery, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 8 Mar 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.
The enhanced recovery after surgery and laparoscopic approach have been proven beneficial in surgery of the colon. However, patients have still pain, nausea and vomiting postoperatively. Postoperative pain is an expected but undesirable effect after an operation. This study will compare Transabdominis Plane (TAP) Block and Quadratus Lumborum (QL) Block with the common postoperative treatment with enteral and parenteral analgesics.
Detailed description
TAP is a recommended multimodal method of reducing postoperative pain in laparoscopic and open surgery. TAP block seems to be feasible and effective in postoperative pain control without increasing morbidity in colon resections. QL block is also performed as one of the perioperative pain management procedures in abdominal surgery. It is regarded as an effective analgesic tool. The dermatomal effects of QL block reach higher than the TAP block, and might explain the better effect of the QL block than TAP blocks on postoperative pain after caesarean delivery. For this study the investigators standardize the type of surgery to be left hemicolectomy. This is the most common procedure on colon.
Power and Sample Size Calculator:
The number of patients required for the study was calculated on the basis of opioid consumption. We were interested in a reduction by 20% in the group given QLB. Assuming α=0,05, we calculated that we need 69 patients (23 in each group) to achieve a power of 80% (β=0.2).
75 adult patients scheduled for left hemicolectomy have to be included.
Subcutaneous wound infiltration at the end of surgery in all patients with ropivacaine 2 mg/ml, 20 ml. Maximum allowed dosis of Ropivacain is 3 mg/kg bodyweight (BW), dosis reduction if BW<70 kg Premedication: Paracetamol 2 g and Diklofenak 100 mg orally. General anaesthesia: TCI: Propofol and Remifentanil Ondansetron 4 mg, dexamethasone 8 mg and Oxycodone 5 mg intravenously at the end of surgery.
Postoperatively:
Oral paracetamol and codeine-fixed combination up to 1000 mg and 60 mg, respectively, every 6 h In case of insufficient analgesia, as judged by the patient, oxycodon 2 - 5 mg IV.
When nausea and vomiting occure postoperatively, ondansetron 4 mg IV administers as the drug of first choice followed by droperidol 0,625 mg IV if the nausea/vomiting persists.
Collected data:
Postoperative pain at rest and during activity evaluated by a 4-points verbal pain score (VPS; with no pain=0, slight pain = 1, Moderate pain = 2, and severe pain = 3) on admission to recovery, and every hour until discharge.
Rescue analgesic consumption during 0 to 4, 4 to 24 and 24 to 48 h. Sedation, nausea and vomiting record by the same 0 - 3 scale (none, slight, moderate, strong) during recovery Time of postoperative mobilization with corresponding pain score. Time of discharge-to-home or ward readiness according to standard criteria, including stable vital signs, no bleeding from the surgical site, ability to void, absence of excessive nausea and pain, and ability to dress and walk without support.
Side effects including nausea and/or vomiting (0 to 4, 4 to 24, and 24 to 48 h), antiemetics administered (0 to 24 and 24 to 48 H), grade of sedation (0 to 10 scale, where 0 = awake, and 10 = aroused on stimulation), and other side effects and symptoms of LA toxicity.
Telephone interview at 24 h, 48 h and 7 days, with questions:
Pain during rest and activity using the VPS Total need of analgesics Sedation Nausea Level of activity Overall satisfaction with the per- and postoperative period on a 0 - 3 scale: not satisfied, slight, moderate or highly satisfied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Left hemicolectomy without nerve blocks | Other | Procedure: Left hemicolectomy, laparoscopic techniqueLeft hemicolectomy, laparoscopic technique Enteral and parenteral analgesics such as paracetamol and oksykodon |
| Left hemicolectomy with TAP block | Active comparator | Procedure: Left hemicolectomy, laparoscopic techniqueLeft hemicolectomy, laparoscopic technique TAP block bilateral with Naropin 3,75 mg/ml, 2 x 20 ml |
| Left hemicolectomy with QL block | Active comparator | Procedure: Left hemicolectomy, laparoscopic techniqueLeft hemicolectomy, laparoscopic technique QL block bilateral with Naropin 3,75 mg/ml, 2 x 20 ml |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 Years
- BMI 20-35
- ASA physical status I-II
Key exclusion criteria (7 listed)
- Allergy to LA
- Chronic pain requiring opioid analgesics
- Patients with atrioventricular block II
- Patients treated with class III antiarrhythmics
- Patients with severe renal and/or hepatic disease
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 |
|---|---|---|
| Left hemicolectomy, laparoscopic techniqueAlso: QL block bilateral with ropivacain 3,75 mg/ml (2 x 20 ml), TAP block with ropivacain 3,75 mg/ml (2 x 20 ml), Traditional analgesics such as paracetamol and oksycodonLeft hemicolectomy, Laparoscopic technique | Procedure or surgery | Left hemicolectomy with QL block, Left hemicolectomy with TAP block, Left hemicolectomy without nerve blocks |
Primary outcome
Use of analgesics - "change" is being assessed
Time frame: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Amount of analgesics used postoperative
6 secondary outcomes
Pain at the incision site - "change" is being assessed
Time frame: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Deep pain and pain on coughing - "change" is being assessed
Time frame: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed
Time frame: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Postoperative nausea and vomiting - "change" is being assessed
Time frame: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Antiemetic administered - "change" is being assessed
Time frame: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Sedation scores - "change" is being assessed
Time frame: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Results publication: 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.
- Results publication: PubMed 27755488Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
- Results publication: PubMed 19376789El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.
- Results publication: PubMed 26735154Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.
- Results publication: PubMed 28667547Pirrera B, Alagna V, Lucchi A, Berti P, Gabbianelli C, Martorelli G, Mozzoni L, Ruggeri F, Ingardia A, Nardi G, Garulli G. Transversus abdominis plane (TAP) block versus thoracic epidural analgesia (TEA) in laparoscopic colon surgery in the ERAS program. Surg Endosc. 2018 Jan;32(1):376-382. doi: 10.1007/s00464-017-5686-7. Epub 2017 Jul 1.
- Results publication: PubMed 28154824Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
- 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.
Jan Sverre Vamnes, MD, Ph.D. principal investigator
Senior Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left hemicolectomy, laparoscopic technique in people with Colon Neoplasm and Surgery, run by Ostfold Hospital Trust at 1 site in Norway.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Mar 2019. 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 Norway. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Sverre Vamnes, MD, Ph.D. (0047 91305016, janvam@so-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of analgesics - "change" is being assessed (time frame: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)). 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 NCT03458689, which also lists 6 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 13 Mar 2019.