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Clinical Trials/CTRI/2021/02/030906
CTRI/2021/02/030906Not yet recruitingNot Applicable

A prospective randomised double blind study of fentanyl and buprenorphine as an adjuvant to intrathecal chloroprocaine for short duration perianal surgeries

Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research1 site in 1 country100 target enrollmentStarted: January 2, 2021Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
100
Locations
1
Primary Endpoint
Postoperative analgesia using VAS Pain scale
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is a randomised double blind trial comparing the effectiveness of adding Burprenorphine and Fentanyl to intrathecal Chloroprocaine for short duration perianal surgeries that will be conducted in Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research. Primary outcome will be postoperative analgesia. Secondary outcomes will be return to bromage score 0, hemodynamic parameters ( Heart rate, Mean arterial pressure and Oxygen saturation) and time to void.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Investigator Blinded

Eligibility Criteria

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

Inclusion Criteria

  • •Age 18-60 years American Society of Anaesthesiologists (ASA) physical status I and II Male and female Patients undergoing subarachnoid block in elective perianal surgeries lasting for less than 60 minutes.

Exclusion Criteria

  • •Patient refusal Patients with local infection at the site of injection Patients with known or ascertained hypersensitivity to local anaesthesia Patient with coagulopathy, bleeding disorders and/or on treatment with anti-coagulants Pregnant women and lactating women.

Outcomes

Primary Outcomes

Postoperative analgesia using VAS Pain scale

Time Frame: Postoperative period, 2nd ,4th, 6th, 8th, 12th,16th, 20th and 24th hour

Secondary Outcomes

  • Return to bromage score 0(Postoperative period upto 4 hours)
  • Time to void(Postoperative period upto 24 hours)
  • Hemodynamic parameters ( Heart rate, Mean arterial pressure, Oxygen saturation)(Baseline, 2 minutes, 4 minutes, 6 minutes, 8 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 240 minutes, 300 minutes, 360 minutes, 420 minutes, 480 minutes, 540 minutes, 600 minutes, 660 minutes, 720 minutes, 780 minutes, 840 minutes, 900 minutes and 960 minutes)

Investigators

Sponsor Class
Private medical college

Study Sites (1)

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