Analgesic Effect of Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery

Not Applicable

Completed

• Conditions: Cholecystectomy; Postoperative Pain; Nerve Block
• Interventions: Drug: Tramadol; Procedure: Ultrasound guided Quadratus Lumborum block; Procedure: Ultrasound guided placebo Quadratus Lumborum block

• Registration Number: NCT03308955
• Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-22
• Primary Completion: 2017-08-22
• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-13
• Status Verified: 2017-12
• Study Completion: 2017-12-02
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grup B	Ultrasound guided Quadratus Lumborum block	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.
Grup S	Ultrasound guided placebo Quadratus Lumborum block	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.
Grup B	Tramadol	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.
Grup S	Tramadol	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Pain Scale	Postoperative 24 hours	Visual Analog Pain Scale was used for pain

Secondary Outcome Measures

Name	Time	Method
tramadol consumption	Postoperative 24 hours	tramadol consumption
side effect profile scores)	Postoperative 24 hour	side effect profile (including nausea and vomiting, hypotension,requirement and the Ramsay Sedation Scale (RSS) scores)
additional analgesic use	Postoperative 24 hour	additional analgesic use

Trial Locations

Locations (1)

University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,; 🇹🇷 Bursa, Turkey