Efficacy of Buprenorphine and Fentanyl transdermal patches in managing postoperative pain following lower limb orthopaedic surgeries - A double blinded randomised controlled trial
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
- Patient screening :
Eligible patients will be identified based on the inclusion and exclusion criteria
Written informed consent will be obtained from all participants
- Baseline data collection :
Demographic details ( Age, gender, weight, BMI)
Preop pain assessment and medical history
Details of the planned surgical procedure
Intraoperative phase
- 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.
- Application of Transdermal patches will be applied within 2 hours post surgery
Postoperative phase
- Pain assessment
Pain scores will be recorded using the VAS score at fixed time intervals :
6,12,24,48, and 72 hours postoperatively
- Adverse effects monitoring
Patient will be monitored for opioid – related side effects (nausea,vomiting,dizziness, respiratory depression)
- 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
Lokeshwar V
Sri Lalithambigai Medical College and Hospital
