The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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
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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

Official Title
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The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy in Day-Case Surgery: A Randomized Controlled Trial

Conditions
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Cholecystectomy, Quadratus Lumborum Block

Intervention / Treatment
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* Procedure: Cholecystectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cholecystectomy without nerve blocks<br>Cholecystectomy, enteral and parenteral analgesics | Procedure: Cholecystectomy<br>* Laparoscopic technique<br>* Other names: Traditional analgesics;|
| Placebo Comparator: Cholecystectomy with placebo nerve block<br>Cholecystectomy, NaCl as a placebo Quadratus lumborum block | Procedure: Cholecystectomy<br>* Laparoscopic technique<br>* Other names: Traditional analgesics;|
| Active Comparator: Cholecystectomy with naropin nerve block<br>Cholecystectomy, Quadratus lumborum block with naropin | Procedure: Cholecystectomy<br>* Laparoscopic technique<br>* Other names: Traditional analgesics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of analgesics -change is being assessed | 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 | 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 | 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 | Amount of different medicaments in mg | 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 | 48 hours(0-4hrs) (4-24hrs) (24-48hrs) |