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Clinical Trials/NCT02824939
NCT02824939
Completed
Not Applicable

Comparison of Ultrasound Guided Quadratus Lumborum Block With Ultrasound Guided TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy: a Prospective Randomized Controlled Trial

Post Graduate Institute of Medical Education and Research, Chandigarh1 site in 1 country96 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Enrollment
96
Locations
1
Primary Endpoint
Cumulative morphine consumption in 24 hours in milligrams
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
May 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Responsible Party
Principal Investigator
Principal Investigator

Kritika Rathour

Junior Resident, Department of Anaesthesia and Intensive Care

Post Graduate Institute of Medical Education and Research, Chandigarh

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cumulative morphine consumption in 24 hours in milligrams

Time Frame: within the first 24 hours after surgery

Secondary Outcomes

  • 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)

Study Sites (1)

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