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Clinical Trials/CTRI/2017/08/009340
CTRI/2017/08/009340RecruitingPhase 2

A study to compare postoperative analgesic efficacy of ropivacaine alone or in combination with dexamethasone for TAP Block in open cholecystectomy

Pt BDSharma PGIMS ROHTAK1 site in 1 country60 target enrollmentStarted: January 13, 2016Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
twenty four hours Tramadol consumption

Study Overview

Brief Summary

This study is a randomized, double blind, parallel group, trail comparing the postoperative analgesic efficacy of 18ml of 0.75% ropivacaine with 2ml of normal saline with 18 ml of o.75% ropivacaine with 2 ml of dexamethasone for TAP block in open cholecystectomy over 60 patients of ASA grade 1-3. The primary outcome will be 24 hr tramadol cosumption. The secondary outcome will be measure include VAS score, nausea score, sedation score and any side effect.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •ASA Grade 1-3.

Exclusion Criteria

  • •1.Contraindication to regional anaesthesia 2.History of local anaesthetic allergy 3.Psychiatric disorder 4.BMI>35kg/sq.m 5.Diabetes Mellitus 6.Chronic opioid use 7.Patient refusal.

Outcomes

Primary Outcomes

twenty four hours Tramadol consumption

Time Frame: postoperative twenty four hours

Secondary Outcomes

  • Time to first request for analgesic, VAS Score,Nausea Score, Sedation Score, Any side effect(24 Hours)

Investigators

Sponsor
Pt BDSharma PGIMS ROHTAK
Sponsor Class
Government medical college

Study Sites (1)

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