- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02910947
Comparative Evaluation of Quadratus Lumborum and Transverses Abdominis Plane Block for Postoperative Pain Relief in Lower Abdominal Surgeries
September 19, 2016 updated by: Dr Vikas Saini, Postgraduate Institute of Medical Education and Research
Two ultrasound guided techniques to give postoperative pain relief to the patients following abdominal surgeries would be compared using scoring systems for pain relief and scientific methods.
while one technique is routinely used, other i.e quadratus lumborum has been recently described and relies on posterior deposition of the drug.
Both the techniques are safe and ultrasound imaging is to be used for guidance.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chandigarh, India, 160012
- PGIMER
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients undergoing lower abdominal surgery 18-60 yrs of age
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: quadratus lumborum
|
The intervention consists of giving ultrasound guided local anaesthetic (0.125% bupivacaine ) in the quadratus lumborum plane or the transversus abdominis plane after randomization.
These planes and technique for these procedures are well described in literature.
|
|
Experimental: TAP(Transversus abdominis plane)
|
The intervention consists of giving ultrasound guided local anaesthetic (0.125% bupivacaine ) in the quadratus lumborum plane or the transversus abdominis plane after randomization.
These planes and technique for these procedures are well described in literature.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
pain relief following abdominal surgery. Visual Analogue Scale (VAS) would be used to record pain at rest. In this patient is asked to describe his/her pain on a scale from 0-10.
Time Frame: 24 hrs
|
24 hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
September 16, 2016
First Submitted That Met QC Criteria
September 19, 2016
First Posted (Estimate)
September 22, 2016
Study Record Updates
Last Update Posted (Estimate)
September 22, 2016
Last Update Submitted That Met QC Criteria
September 19, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INT/IEC/2016/2146
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.