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临床试验/CTRI/2024/07/070061
CTRI/2024/07/070061尚未招募3 期

Comparison Of Analgesic Efficacy Of Transdermal Buprenorphine For Postoperative Pain With Control Group In Patients Undergoing Lumbar Discectomy

Sapthagiri Institute Of Medical Sciences And Research Centre1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
To compare postoperative VAS score in patients receiving buprenorphine patch v/s control who wont receive buprenorphine patch

研究概览

简要总结

Transdermal patches for NSAIDS and opioids offer the advantage of sustained drug delivery, bioavailability, and avoidance of first-pass metabolism which reduces systemic effects. They have a one-time application, reduce workload on health-care workers, and prevent waxing-waning of analgesia due to diminishing blood levels.It has been widely applied in treating chronic low back pain displaying excellent results.This study is undertaken to see the effect of transdermal buprenorphine on postoperative pain after lumbar discectomy.

Patients posted for lumbar discectomy in Sapthagiri Institute of Medical Sciences  who fulfil the inclusion criteria will be enrolled for the study. Patients will be randomised into 2 equal groups of 42 each  [Group B and Group C] using computer generated table of random numbers.

Group B: Receiving transdermal buprenorphine patch 10 mg the night before surgery

Group C : Control group who will not receive buprenorphine patch

Group B patients will receive transdermal Buprenorphine 10mcg/hr patch night before surgery. Analgesia IV Paracetamol 1g  will be given after intubation in both groups. Intraoperative hemodynamic parameters like HR , BP , SPO2  will be noted at baseline, induction, 5 mins and 10 mins. VAS score , HR , BP , SPO2 will be assessed at 0, 2, 4, 8, 12, 24 and 48hrs in both the groups and recorded. Inj Tramadol 2 mg/kg (maximum 100mg) IV will be administered when VAS>3 as rescue analgesic.VAS score, time of first rescue analgesia, total analgesic consumption will be recorded in  first 48 hours and compared between both groups.


研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • ASA grade I and II Age 18-60yrs Posted for lumbar discectomy.

排除标准

  • Patients not willing to participate in the study Patients on any other form of opioid therapy for chronic pain History of drug allergy or application.

结局指标

主要结局

To compare postoperative VAS score in patients receiving buprenorphine patch v/s control who wont receive buprenorphine patch

时间窗: VAS score , HR , BP , SPO2 will be assessed at 0, 2, 4, 8, 12, 24 and 48hrs in both the groups and recorded

次要结局

  • Time to first rescue analgesic.(Total rescue analgesic.)

研究者

发起方
Sapthagiri Institute Of Medical Sciences And Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Lekha Shree R

Sapthagiri Institute Of Medical Sciences And Research Centre

研究点 (1)

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