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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Transversus Abdominis Plane (TAP) Block
Quadratus Lumborum (QL) Block
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Post Graduate Institute of Medical Education and Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Transversus Abdominis Plane group

Quadratus Lumborum group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Cumulative morphine consumption in 24 hours in milligrams

Secondary Outcome Measures

Pain scores at rest and on movement as measured by numeric rating scale (0 to 10)
Time to first demand of rescue analgesic in hours
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)
Incidence of block related complications
Incidence of adverse effects related to opioid use (derrived from incidence of nausea and vomiting, sedation and respiratory depression)
Patient satisfaction as measured by numeric rating scale (0 to 10)

Full Information

First Posted
June 27, 2016
Last Updated
December 12, 2017
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT02824939
Brief Title
Comparison of Quadratus Lumborum Block With TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy
Official Title
Comparison of Ultrasound Guided Quadratus Lumborum Block With Ultrasound Guided TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transversus Abdominis Plane group
Arm Type
Experimental
Arm Title
Quadratus Lumborum group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Transversus Abdominis Plane (TAP) Block
Intervention Description
0.5 ml/kg of 0.25 % Bupivacaine deposited in the transversus abdominis plane under ultrasound guidance postoperatively
Intervention Type
Other
Intervention Name(s)
Quadratus Lumborum (QL) Block
Intervention Description
0.5 ml/kg of 0.25 % Bupivacaine deposited in the anterolateral aspect of the quadratus lumborum muscle under ultrasound guidance postoperatively
Primary Outcome Measure Information:
Title
Cumulative morphine consumption in 24 hours in milligrams
Time Frame
within the first 24 hours after surgery
Secondary Outcome Measure Information:
Title
Pain scores at rest and on movement as measured by numeric rating scale (0 to 10)
Time Frame
within the first 24 hours after surgery
Title
Time to first demand of rescue analgesic in hours
Time Frame
within the first 24 hours after surgery
Title
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)
Time Frame
while performing block
Title
Incidence of block related complications
Time Frame
within the first 24 hours after surgery
Title
Incidence of adverse effects related to opioid use (derrived from incidence of nausea and vomiting, sedation and respiratory depression)
Time Frame
within the first 24 hours after surgery
Title
Patient satisfaction as measured by numeric rating scale (0 to 10)
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 morbid obesity/ sleep apnoea
Facility Information:
Facility Name
Post Graduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Comparison of Quadratus Lumborum Block With TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy

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