Buprenorphine patch as a preemptive analgesia in fracture femur patients - A prospective randomized controlled study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess effectiveness of buprenorphine patch applied preoperatively 24 hours prior as perioperative analgesia
研究概览
简要总结
A prospective observational study which will be conducted on 80 patients divided into 2 groups with 40 patients in each group of either gender belonging to ASA1 or ASA2 status, aged 18-60 years old, requiring fracture femur surgery under subarachnoid block.
Group I- will receive buprenorphine patch of 10mg 24 hours prior surgeryGroup II- will receive placebo patch.
The transdermal patch will be applied 24 h preoperatively, as preemptive analgesia to get maximum benefit as plasma concentration increases only slowly within 12–24 h.
Baseline VAS along with vitals was recorded in the form of heart rate, blood pressure, saturation and respiratory rate.
Followed by VAS which will be recorded on the day of surgery at 8am, at the time of mobilization, at positioning for subarachnoid block and postoperatively at 4, 8, 12 and 24 hourly.
Visual analogue scale (VAS) will be used to evaluate the degree of pain in patients: 0 to 2 scores indicated excellent; 3 to5 scores indicated good; 6 to8 scores indicated fair; and 9 to 10 scores indicated poor. The need of rescue analgesia will be recorded. The rescue analgesia will be given if VAS >4. The first rescue will be 1g paracetamol intravenously. If still VAS is more than 4, then ketorolac 30 mg, fllowed by 75 mg diclofencac intravenously will be used. The requirement of rescue analgesics will be in terms of ketorolac equivalents- 30 mg = 1g PCM=75 mg diclofenac. Total analgesic required in first 24 hours will be noted and any further intervention to reduce pain will also be noted
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •Patients requiring fracture femur surgeries under subarachnoid blocks.
排除标准
- •1- Patients who are not willing to participate 2- Patients with multiple fractures that would add to the discomfort and need of epidural 3- Obese patients 4- Severe liver or cardiorespiratory disease 5- Altered mental status 6- Patients on antidepressants 7- Patients with allergic history to opioids 8- Patients with chronic pain because of some other conditions or having arthritic pain.
- •9- Conditions requiring general anesthesia.
结局指标
主要结局
To assess effectiveness of buprenorphine patch applied preoperatively 24 hours prior as perioperative analgesia
时间窗: 4 hours, 8 hours, 12 hours and 24 hours after surgery
次要结局
- 1- To assess analgesic requirements(2- To assess patient satisfaction)
研究者
Om vasavi palam
Nizams Institute of medical sciences, Hyderabad