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
Study Sites (1)
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