CTRI/2016/06/007039CompletedPhase 3
A Comparative Study of ropivacaine with fentanyl and bupivacaine with fentanyl for postoperative epidural analgesia after major abdominal oncosurgery.
Rajiv Gandhi Cancer Institute and Research Centre1 site in 1 country60 target enrollmentStarted: March 25, 2015Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- VAS score for postoperative pain
Study Overview
Brief Summary
This is a prospective, randomized, double blind ,parallel group, active controlled, single centric interventional trial comparing the analgesic efficacy of epidural ropivacaine with fentanyl and bupivacaine with fentanyl after major abdominal oncosurgery at fixed time points in 60 patients of either sex at Rajiv Gandhi Cancer Institute and Research Centre.VAS Sore for postoperative pain relief is the primary outcome measure and Bromage Score for motor blockade is the secondary outcome measure at various time points of 10 minutes, 1hour, 6 hours, 12 hours, 18 hours and 24 hours postoperatively
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 45.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Weight between 45-75 Kg ASA Physical Status I, II and III Elective major oncosurgery via a vertical, midline infraumbilical incision.
Exclusion Criteria
- •Patient refusal for Regional Anaesthesia Contraindications for Regional Anaesthesia(coagulopathy,regional infection) History of allergic reaction to Bupivacaine, Ropivacaine or Fentanyl Spinal deformity.
Outcomes
Primary Outcomes
VAS score for postoperative pain
Time Frame: 10mins,1hour,6hour,12hour,18 hour and 24 hour
Secondary Outcomes
- Bromage Score for motor blockade(10 mins,1hour,6 hours,12 hours,18 hours and 24 hours)
Investigators
Study Sites (1)
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