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临床试验/CTRI/2025/08/092972
CTRI/2025/08/092972尚未招募不适用

Efficacy of Buprenorphine and Fentanyl transdermal patches in managing postoperative pain following lower limb orthopaedic surgeries - A double blinded randomised controlled trial

Lokeshwar Vijayakumar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1. Postoperative Pain Level

研究概览

简要总结

This study is a comparative evaluation of buprenorphine (10 µg/h) and fentanyl (25 µg/h) transdermal patches in the context of lower limb orthopedic surgeries in patients with BMI of more than 25. This study aims to assess the analgesic efficacy of these patches, alongside noting hemodynamic variability and potential adverse effects, to establish optimized pain management strategies for patients undergoing lower limb orthopaedic procedures.Preoperative phase

  1. Patient screening :

Eligible patients will be identified based on the inclusion and exclusion criteria

Written informed consent will be obtained from all participants

  1. Baseline data collection :

Demographic details ( Age, gender, weight, BMI)

Preop pain assessment and medical history

Details of the planned surgical procedure

Intraoperative phase

  1. Standardized anaesthetic protocol :

All patients will receive the same anaesthesia regimen to minimise variability in postoperative pain outcomes.

Duration and type of surgery will be recorded.

  1. Application of Transdermal patches will be applied within 2 hours post surgery

Postoperative phase

  1. Pain assessment

Pain scores will be recorded using the VAS score at fixed time intervals :

6,12,24,48, and 72 hours postoperatively

  1. Adverse effects monitoring

Patient will be monitored  for opioid – related side effects (nausea,vomiting,dizziness, respiratory depression)

  1. Patient satisfaction

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 65.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 and 2 patients
  • Patients with BMI of more than 25
  • Patients scheduled for elective lower lib surgeries and who have given consent for the study
  • Age group 18 to 65 years.

排除标准

  • Exclusion criteria:
  • ASA physical status of more than 3
  • Patients posted for emergency surgeries
  • Patients with history of allergy to study drugs
  • Pregnant and lactating woman
  • Patients with impaired pulmonary function
  • Patients with opioid intolerance.

结局指标

主要结局

1. Postoperative Pain Level

时间窗: Post surgery | 6 hours | 12 hours | 24 hours | 48 hours | 72 hours

Measurement Method: Visual Analog Scale (VAS), scored from 1 (no pain) to 10 (severe pain).

时间窗: Post surgery | 6 hours | 12 hours | 24 hours | 48 hours | 72 hours

次要结局

  • 2. Sedation Levels(Measurement Method: Ramsay Sedation Score (scale: 1 to 5).)

研究者

发起方
Lokeshwar Vijayakumar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Lokeshwar V

Sri Lalithambigai Medical College and Hospital

研究点 (1)

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