- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03437187
The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy
The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy in Day-Case Surgery: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ostfold
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Grålum, Ostfold, Norway, 1714
- Ostfold Hospital Trust, Moss
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-80 Years
- BMI 20-35
- ASA physical status I-II
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cholecystectomy without nerve blocks
Cholecystectomy, enteral and parenteral analgesics
|
Laparoscopic technique
Other Names:
|
Placebo Comparator: Cholecystectomy with placebo nerve block
Cholecystectomy, NaCl as a placebo Quadratus lumborum block
|
Laparoscopic technique
Other Names:
|
Active Comparator: Cholecystectomy with naropin nerve block
Cholecystectomy, Quadratus lumborum block with naropin
|
Laparoscopic technique
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of analgesics -"change" is being assessed
Time Frame: 1 week (0-4hrs) (4-24hrs) (24-48hrs)
|
Amount of analgesics used postoperative
|
1 week (0-4hrs) (4-24hrs) (24-48hrs)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain at the incision site - "change" is being assessed
Time Frame: 48 hours (0-4hrs) (4-24hrs) (24-48hrs)
|
NRS (Numeric Rating Scale; 0 - 10) 0 = no pain, 10 = severe pain
|
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)
|
NRS (Numeric Rating Scale; 0 - 10) 0 = no pain, 10 = severe pain
|
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)
|
Amount of different medicaments in mg
|
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)
|
0-3 score where 0=none, 1=little nausea, 2=can not eat, 3=vomiting
|
48 hours(0-4hrs) (4-24hrs) (24-48hrs)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- El-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. Erratum In: Br J Anaesth. 2009 Oct;103(4):622.
- Petersen 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.
- Blanco 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. Erratum In: Reg Anesth Pain Med. 2018;43:111.
- 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.
- Murouchi 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.
- Ueshima 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1812
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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