Randomized Double-blind Trial Comparing the Post-operative Analgesic Efficacy of Local Wound Infiltration With Bupivacaine Alone to Bupivacaine With Clonidine in Posterior Spine Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Mean Area under curve
研究概览
简要总结
The objective of this prospective randomized double-blind study is to evaluate the added analgesic value of clonidine to the conventional local bupivacaine wound infiltration in posterior spine surgery.
详细描述
Patients candidates to posterior spine surgery (Micro-discectomy, Lumbar laminectomy with or without fusion, cervical laminectomy) are asked to participate to this prospective study. After verification of inclusion and exclusion criteria, patients consenting to enter the study are randomly assigned to one of the following subgroups: 1-Pre-incisional wound infiltration with 20 mL of bupivacaine 0.25%. 2- Pre-incisional wound infiltration with 150 μg of clonidine with 20 mL of bupivacaine 0.25%. Demographic parameters, co-morbidities and other pre and per operative medical data are noted. In the post-operative period, patients received a standardized post-operative analgesic protocol (NSAI and paracetamol). Patients are asked to fill their pain diary using Visual Analog Scale (VAS) from day 0 till day 8 after surgery. Morphine rescue consumption is noted. Finally, the percentage of global subjective patient satisfaction regarding the post-operative wound pain is noted from 0 to 100.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 72 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First (not recurrent) posterior spinal surgery at the operated site
- •American Society of Anesthesiologists class I or II (operative risk)
排除标准
- •Allergy to local anesthetics or to clonidine
- •Pregnancy
- •Raynaud's syndrome
- •Thromboangiitis obliterans
- •History of substance abuse
- •Current treatment with corticosteroids
研究组 & 干预措施
Clonidine
Clonidine 150μg added to bupivacaine in a local infiltration before wound incision
干预措施: Clonidine (Drug)
Bupivacaine
Bupivacaine 0.25 % alone in the wound infiltration
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Mean Area under curve
时间窗: From the day of surgery till the 8th postoperative day (9 days and 8 nights=200h
Pain is assessed on numeric rating scale (NRS) 8times/day during the first 3 days, 3times/day during the next 6days and one mean value during the night. The mean intensity of daily pain is obtained from the different values mentioned during day and night corrected by the duration covered by every value. It may vary from 0 to 10.
次要结局
- Area under Curve (AUC) of pain(Calculated at Day 0-2, Day3-5, Day6-8 and all along the follow-up from Day0 till Day8)
- Daily rescue opiates consumption(From the day of surgery till the 3rd postoperative day)
- Global subjective patient satisfaction of post-operative wound pain control(Assessed at the end of follow-up on Day 8)
研究者
Dr Joseph Maarrawi
Assistant Professor : Researcher - Pain Specialist - Neurosurgeon
St Joseph University, Beirut, Lebanon
