Comparison of Quadratus Lumborum Block With TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Other: Transversus Abdominis Plane (TAP) Block; Other: Quadratus Lumborum (QL) Block

• Registration Number: NCT02824939
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

This is a randomised controlled trial which will compare the Quadratus Lumborum (QL) Block with the Transversus Abdominis Plane (TAP) Block in terms of analgesic efficacy, ease of performance and safety when administered postoperatively in patients who undergo laparoscopic nephrectomy.

To fulfill this purpose, three groups of patients each with 32 patients, will be formed. Patients in the Transversus Abdominis Plane (TAP) group and Quadratus Lumborum (QL) group will each receive the respective blocks with 0.4 ml/kg of 0.25% Bupivacaine, after completion of surgery. The third (Control group) will not receive any blocks. After shifting patients to recovery all three groups will be put into intravenous patient controlled analgesia (PCA) Morphine as rescue analgesic regimen as per a set protocol. Morphine consumption over the first postoperative 24 hours, ease of performance of individual blocks and associated adverse events, adverse events associated with opioid use, patient recovery and satisfaction will be noted.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-07-03
• Study First Posted: 2016-07-07
• Study Start: 2016-09
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-12
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• patients between 18-65 years of age,
• ASA class I or II,
• undergoing elective unilateral laparoscopic nephrectomy
• under general anaesthesia

Exclusion Criteria

Patients with any of the following:

• refusal to participate in the study
• coagulopathy/ thrombocytopenia
• localised infection at the proposed site of injection
• inability to comprehend the scoring systems to be employed or use PCA due to physical or mental problems
• known allergy to the drugs to be used (local anesthetics, opioids)
• opioid tolerance/ dependence
• renal impairment
• hepatic impairment
• known cardio-respiratory impairment
• morbid obesity/ sleep apnoea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transversus Abdominis Plane group	Transversus Abdominis Plane (TAP) Block	-
Quadratus Lumborum group	Quadratus Lumborum (QL) Block	-

Primary Outcome Measures

Name	Time	Method
Cumulative morphine consumption in 24 hours in milligrams	within the first 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse effects related to opioid use (derrived from incidence of nausea and vomiting, sedation and respiratory depression)	within the first 24 hours after surgery
Incidence of block related complications	within the first 24 hours after surgery
Pain scores at rest and on movement as measured by numeric rating scale (0 to 10)	within the first 24 hours after surgery
Patient satisfaction as measured by numeric rating scale (0 to 10)	24 hours after surgery
Time to first demand of rescue analgesic in hours	within the first 24 hours after surgery
Ease of performing the respective blocks (assessed by time required to perform the blocks in minutes and number of attempts required to perform the blocks)	while performing block

Trial Locations

Locations (1)

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India