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A clinical trial to study the effects of two pain relief drugs, fentanyl and buprenorphine added to chloroprocaine, a numbing drug injected at the lower back into a space that carries nerves in patients undergoing operations around anus

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/030906
Enrollment
100
Registered
2021-02-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Buprenorphine as additive to intrathecal choloroprocaine: 75 micrograms Buprenorphine (0.5 ml) as additive to intrathecal 1% choloroprocaine 30mg (3ml) for patients undergoing short du

Sponsors

Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research
Lead Sponsor

Eligibility

Inclusion criteria

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. BMI

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Postoperative analgesia using VAS Pain scaleTimepoint: Postoperative period, 2nd ,4th, 6th, 8th, 12th,16th, 20th and 24th hour

Secondary

MeasureTime frame
Hemodynamic parameters ( Heart rate, Mean arterial pressure, Oxygen saturation)Timepoint: 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;Return to bromage score 0Timepoint: Postoperative period upto 4 hours;Time to voidTimepoint: Postoperative period upto 24 hours

Countries

India

Contacts

Public ContactDr Arun Sekar G

Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research

arun1834@yahoo.co.in9843136969

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026