Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02824939
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Kritika Rathour, Postgraduate Institute of Medical Education and Research

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Other: Transversus Abdominis Plane (TAP) Block Other: Quadratus Lumborum (QL) Block Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : September 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: Transversus Abdominis Plane group Other: Transversus Abdominis Plane (TAP) Block
0.5 ml/kg of 0.25 % Bupivacaine deposited in the transversus abdominis plane under ultrasound guidance postoperatively

Experimental: Quadratus Lumborum group Other: Quadratus Lumborum (QL) Block
0.5 ml/kg of 0.25 % Bupivacaine deposited in the anterolateral aspect of the quadratus lumborum muscle under ultrasound guidance postoperatively

No Intervention: Control group



Primary Outcome Measures :
  1. Cumulative morphine consumption in 24 hours in milligrams [ Time Frame: within the first 24 hours after surgery ]

Secondary Outcome Measures :
  1. 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 ]
  2. Time to first demand of rescue analgesic in hours [ Time Frame: within the first 24 hours after surgery ]
  3. 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 ]
  4. Incidence of block related complications [ Time Frame: within the first 24 hours after surgery ]
  5. 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 ]
  6. Patient satisfaction as measured by numeric rating scale (0 to 10) [ Time Frame: 24 hours after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824939


Locations
Layout table for location information
India
Post Graduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Kritika Rathour, Junior Resident, Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02824939    
Other Study ID Numbers: NK/2663/MS/3121-22
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations