Analgesic Effect of Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery

Study Overview
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Brief Summary
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Laparoscopy is frequently used today for intraabdominal operations. Laparoscopic procedure has become the treatment of choice for many patients with symptomatic cholelithiasis. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain, despite a multimodal analgesic regime. This is a randomised controlled trial efficay of the Quadratus Lumborum (QL) Block in terms of analgesic efficacy in patients who undergo laparoscopic cholecystectomy.

Official Title
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Analgesic Effect of Ultrasound Guided Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery

Conditions
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Nerve Block, Cholecystectomy, Postoperative Pain

Intervention / Treatment
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* Drug: Tramadol
* Procedure: Ultrasound guided Quadratus Lumborum block
* Procedure: Ultrasound guided placebo Quadratus Lumborum block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent Laparoscopic Cholecystectomy Exclusion Criteria: Previous history of opioid use preoperatively, Allergy to local anesthetics, The presence of any systemic infection, Uncontrolled arterial hypertension, Uncontrolled diabetes mellitus.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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
Interventional Model Description: prospective,randomized,single blind
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Grup B<br>Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg % 0.25 bupivakain+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg. | Drug: Tramadol<br>* 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.<br>Procedure: Ultrasound guided Quadratus Lumborum block<br>* Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg % 0.25 bupivakain+400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.<br>|
| Sham Comparator: Grup S<br>Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg saline % 0,9+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg. | Drug: Tramadol<br>* 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.<br>Procedure: Ultrasound guided placebo Quadratus Lumborum block<br>* Ultrasound guided placebo Quadratus Lumborum block type II with 0.3 ml/kg saline % 0,9+400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Scale | Visual Analog Pain Scale was used for pain | Postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tramadol consumption | tramadol consumption | Postoperative 24 hours | 
| side effect profile scores) | side effect profile (including nausea and vomiting, hypotension,requirement and the Ramsay Sedation Scale (RSS) scores) | Postoperative 24 hour | 
| additional analgesic use | additional analgesic use | Postoperative 24 hour |