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 个研究点分布在 1 个国家目标入组 100 人开始时间: 2021年1月2日最近更新: 2021年1月29日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research
入组人数: 100
试验地点: 1
主要终点: Postoperative analgesia using VAS Pain scale

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Coin toss, Lottery, toss of dice, shuffling cards etc
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•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.

排除标准

•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.

结局指标

主要结局

Postoperative analgesia using VAS Pain scale

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

次要结局

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)

研究者

发起方

Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research

申办方类型

Private medical college

研究点 (1)

Loading locations...

相似试验

终止

3 期

Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis PainOsteoarthritis

NCT00312221Purdue Pharma LP418

已完成

3 期

Safety and Effectiveness of Buprenorphine Transdermal System in Elderly Subjects With Chronic Pain: Pilot Study.Chronic Pain

NCT00313833Purdue Pharma LP100

已完成

3 期

Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or KneeOsteoarthritis

NCT00313846Purdue Pharma LP529

已完成

4 期

A Study Comparing Norspan Patch and Oral TramadolOsteoarthritis

NCT01019265Mundipharma Korea Ltd170

尚未招募

4 期

To compare the incidence of hypotension and bradycardia by using two sympathomimetic drugs ,phenylephrine and noradrenaline among patients undergoing cesarean section under spinal anesthetia

CTRI/2023/06/054376Dr Y Surekha128