CholecystectomyNCT03437187
The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy
A study testing Cholecystectomy in people with Cholecystectomy and Quadratus Lumborum Block, run by Ostfold Hospital Trust at 1 site in Norway.
Trial summary
The enhanced recovery after surgery and laparoscopic approach is essential after day-case surgery. The patients want to go home early without pain and nausea, and the hospitals need the post-operative capacity for more patients. Many patients have pains, nausea and vomiting postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholecystectomy, Quadratus Lumborum Block
- What is being tested?
- Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteNorway
- Study dates
- 20 Jan 2018to 18 Feb 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 local anaesthetics
- 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.
About this study
Official title: The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy in Day-Case Surgery: A Randomized Controlled Trial
The enhanced recovery after surgery and laparoscopic approach is essential after day-case surgery. The patients want to go home early without pain and nausea, and the hospitals need the post-operative capacity for more patients. Many patients have pains, nausea and vomiting postoperatively. Postoperative pain is an expected but undesirable effect after an operation. The aim of the study is to find out if a bilateral quadratus lumborum block has a beneficial effect after a cholecystectomy.
Read the detailed description
QLB (quadratus lumborum block) is a recommended multimodal method of reducing postoperative pain in laparoscopic and open surgery. Quadratus lumborum block for postoperative pain after caesarean section 2015). Transversus abdominis plane (TAP) block seems to be feasible and effective in postoperative pain control without increasing morbidity in cholecystectomy. QLB 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 QLB reach higher than the TAP block and might explain the better effect of the QLB than TAP blocks on postoperative pain after caesarean delivery. A randomized double blinded clinical trial with TAP block in patients scheduled for cholecystectomy is performed, but there is no good data for the QLB. For this study the investigators standardize the type of surgery to be laparoscopic day-case cholecystectomy, and we use the anterior (transmuscular) QLB.
Power and Sample Size Calculator The number of patients required for the study was calculated on the basis of opioid consumption. The investigators are interested in a reduction by 20% in the group given QLB. Assuming α=0,05, the calculation shows a need of 69 patients (23 in each group) to achieve a power of 80% (β=0.2).
75 adult patients scheduled for cholecystectomy have to be included. Subcutaneous wound infiltration at the end of surgery in all patients with ropivacaine 2 mg/ml, 10 ml. Maximum allowed dosis is 3 mg/kg BW (BodyWeight). Dosis reduction if BW<70 kg. All three groups receive necessary analgesics oral or parenteral.
Premedication: Paracetamol 2g and Diklofenak 100 mg
General anesthesia: TCI (Target Control of Infusion): Propofol and Remifentanil, Ondansetron 4 mg and Decadron 8 mg iv preoperatively. Oxycodon 5 mg iv at the end of the procedure.
Surgical procedure: Cholecystectomy, laparoscopic and day-case.
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 1 - 5 mg IV.
- When nausea and vomiting occur 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 evaluates by a 0 - 10 scale (NRS) on admission to recovery, and every hour until discharge.
- Rescue analgesic consumption during 0 to 4, 4 to 24 and 24 to 48 h.
- 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 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), and other side effects and symptoms of LA (Local Anaesthetic) toxicity.
Telephone interview at 24 h and 48 h
- Conditions
- Cholecystectomy, Quadratus Lumborum Block
- Being tested
- Cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecystectomyProcedure or surgery
Also called Quadratus lumborum block with Naropin, Quadratus lumborum block with Nacl, Traditional analgesics
Laparoscopic technique
| Study group | Role | What they receive |
|---|---|---|
| Cholecystectomy without nerve blocks | Other | Cholecystectomy, enteral and parenteral analgesics Receives: Procedure: Cholecystectomy |
| Cholecystectomy with placebo nerve block | Placebo comparator | Cholecystectomy, NaCl as a placebo Quadratus lumborum block Receives: Procedure: Cholecystectomy |
| Cholecystectomy with naropin nerve block | Active comparator | Cholecystectomy, Quadratus lumborum block with naropin Receives: Procedure: Cholecystectomy |
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 (0-4hrs) (4-24hrs) (24-48hrs)
Secondary outcomes (4)
Pain at the incision site - "change" is being assessed
NRS (Numeric Rating Scale; 0 - 10) 0 = no pain, 10 = severe pain
Measured: 48 hours (0-4hrs) (4-24hrs) (24-48hrs)
Deep pain and pain on coughing - "change" is being assessed
NRS (Numeric Rating Scale; 0 - 10) 0 = no pain, 10 = severe pain
Measured: 48 hours (0-4hrs) (4-24hrs) (24-48hrs)
Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed
Amount of different medicaments in mg
Measured: 48 hours(0-4hrs) (4-24hrs) (24-48hrs)
Postoperative nausea and vomiting - "change" is being assessed
0-3 score where 0=none, 1=little nausea, 2=can not eat, 3=vomiting
Measured: 48 hours(0-4hrs) (4-24hrs) (24-48hrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start20 Jan 2018
- Primary completion31 Mar 2019
- Study completion18 Feb 2020
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 CholecystectomyStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Sverre Vamnes, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437187
- Sponsor's protocol ID
- 1812
- Status last verified
- Feb 2020
- First submitted
- 22 Jan 2018
- Last updated
- 20 Feb 2020
- 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 26735154Petersen PL, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB, Mathiesen O. The beneficial effect of transversus abdominis plane block after laparoscopic cholecystectomy in day-case surgery: a randomized clinical trial. Anesth Analg. 2012 Sep;115(3):527-33. doi: 10.1213/ANE.0b013e318261f16e. Epub 2012 Jul 4.
PubMed 22763903Ueshima 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 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy in Day-Case Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03437187
- Acronym / sponsor ID
- 1812
- Conditions
- Cholecystectomy, Quadratus Lumborum Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 19 Feb 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 is essential after day-case surgery. The patients want to go home early without pain and nausea, and the hospitals need the post-operative capacity for more patients. Many patients have pains, nausea and vomiting postoperatively. Postoperative pain is an expected but undesirable effect after an operation. The aim of the study is to find out if a bilateral quadratus lumborum block has a beneficial effect after a cholecystectomy.
Detailed description
QLB (quadratus lumborum block) is a recommended multimodal method of reducing postoperative pain in laparoscopic and open surgery. Quadratus lumborum block for postoperative pain after caesarean section 2015). Transversus abdominis plane (TAP) block seems to be feasible and effective in postoperative pain control without increasing morbidity in cholecystectomy. QLB 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 QLB reach higher than the TAP block and might explain the better effect of the QLB than TAP blocks on postoperative pain after caesarean delivery. A randomized double blinded clinical trial with TAP block in patients scheduled for cholecystectomy is performed, but there is no good data for the QLB. For this study the investigators standardize the type of surgery to be laparoscopic day-case cholecystectomy, and we use the anterior (transmuscular) QLB.
Power and Sample Size Calculator The number of patients required for the study was calculated on the basis of opioid consumption. The investigators are interested in a reduction by 20% in the group given QLB. Assuming α=0,05, the calculation shows a need of 69 patients (23 in each group) to achieve a power of 80% (β=0.2).
75 adult patients scheduled for cholecystectomy have to be included. Subcutaneous wound infiltration at the end of surgery in all patients with ropivacaine 2 mg/ml, 10 ml. Maximum allowed dosis is 3 mg/kg BW (BodyWeight). Dosis reduction if BW<70 kg. All three groups receive necessary analgesics oral or parenteral.
Premedication: Paracetamol 2g and Diklofenak 100 mg
General anesthesia: TCI (Target Control of Infusion): Propofol and Remifentanil, Ondansetron 4 mg and Decadron 8 mg iv preoperatively. Oxycodon 5 mg iv at the end of the procedure.
Surgical procedure: Cholecystectomy, laparoscopic and day-case.
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 1 - 5 mg IV.
- When nausea and vomiting occur 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 evaluates by a 0 - 10 scale (NRS) on admission to recovery, and every hour until discharge.
- Rescue analgesic consumption during 0 to 4, 4 to 24 and 24 to 48 h.
- 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 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), and other side effects and symptoms of LA (Local Anaesthetic) toxicity.
Telephone interview at 24 h and 48 h
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cholecystectomy without nerve blocks | Other | Procedure: CholecystectomyCholecystectomy, enteral and parenteral analgesics |
| Cholecystectomy with placebo nerve block | Placebo comparator | Procedure: CholecystectomyCholecystectomy, NaCl as a placebo Quadratus lumborum block |
| Cholecystectomy with naropin nerve block | Active comparator | Procedure: CholecystectomyCholecystectomy, Quadratus lumborum block with naropin |
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 local anaesthetics
- 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 |
|---|---|---|
| CholecystectomyAlso: Quadratus lumborum block with Naropin, Quadratus lumborum block with Nacl, Traditional analgesicsLaparoscopic technique | Procedure or surgery | Cholecystectomy with naropin nerve block, Cholecystectomy with placebo nerve block, Cholecystectomy without nerve blocks |
Primary outcome
Use of analgesics -"change" is being assessed
Time frame: 1 week (0-4hrs) (4-24hrs) (24-48hrs)
Amount of analgesics used postoperative
4 secondary outcomes
Pain at the incision site - "change" is being assessed
Time frame: 48 hours (0-4hrs) (4-24hrs) (24-48hrs)
Deep pain and pain on coughing - "change" is being assessed
Time frame: 48 hours (0-4hrs) (4-24hrs) (24-48hrs)
Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed
Time frame: 48 hours(0-4hrs) (4-24hrs) (24-48hrs)
Postoperative nausea and vomiting - "change" is being assessed
Time frame: 48 hours(0-4hrs) (4-24hrs) (24-48hrs)
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 20 Feb 2020.
- 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 22763903Petersen PL, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB, Mathiesen O. The beneficial effect of transversus abdominis plane block after laparoscopic cholecystectomy in day-case surgery: a randomized clinical trial. Anesth Analg. 2012 Sep;115(3):527-33. doi: 10.1213/ANE.0b013e318261f16e. Epub 2012 Jul 4.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecystectomy in people with Cholecystectomy and Quadratus Lumborum Block, 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: finished, as of the sponsor's last update on 20 Feb 2020. 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. 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.
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?
Use of analgesics -"change" is being assessed (time frame: 1 week (0-4hrs) (4-24hrs) (24-48hrs)). 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 NCT03437187, 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 20 Feb 2020.