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Comparative Evaluation of Quadratus Lumborum and Transverses Abdominis Plane Block for Postoperative Pain Relief in Lower Abdominal Surgeries

Primary Purpose

Pain Relief to the Patient Following Abdominal Surgeries

Status

Unknown status

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

ultrasound guided quadratus lumborum or Transversus Abdominis plane block

About this trial

This is an interventional supportive care trial for Pain Relief to the Patient Following Abdominal Surgeries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

patients undergoing lower abdominal surgery 18-60 yrs of age

Exclusion Criteria:

none

Sites / Locations

PGIMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

quadratus lumborum

TAP(Transversus abdominis plane)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02910947

First Posted

September 16, 2016

Last Updated

September 19, 2016

Sponsor

Postgraduate Institute of Medical Education and Research

1. Study Identification

Unique Protocol Identification Number

NCT02910947

Brief Title

Comparative Evaluation of Quadratus Lumborum and Transverses Abdominis Plane Block for Postoperative Pain Relief in Lower Abdominal Surgeries

Official Title

Comparative Evaluation of Quadratus Lumborum and Transverses Abdominis Plane Block for Postoperative Pain Relief in Lower Abdominal Surgeries

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2016 (undefined)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Postgraduate Institute of Medical Education and Research

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Pain Relief to the Patient Following Abdominal Surgeries

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

quadratus lumborum

Arm Type

Experimental

Arm Title

TAP(Transversus abdominis plane)

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

ultrasound guided quadratus lumborum or Transversus Abdominis plane block

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients undergoing lower abdominal surgery 18-60 yrs of age Exclusion Criteria: none

Facility Information:

Facility Name

PGIMER

City

Chandigarh

ZIP/Postal Code

160012

Country

India

Facility Contact:

First Name & Middle Initial & Last Name & Degree

vikas Saini, MD

Phone

7087008119

drvsaini@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Comparative Evaluation of Quadratus Lumborum and Transverses Abdominis Plane Block for Postoperative Pain Relief in Lower Abdominal Surgeries

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