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临床试验/NCT01902108
NCT01902108已完成4 期

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

St Joseph University, Beirut, Lebanon1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Clonidine 150μg added to bupivacaine in a local infiltration before wound incision

干预措施: Clonidine (Drug)

Bupivacaine

Active Comparator

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

发起方
St Joseph University, Beirut, Lebanon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Joseph Maarrawi

Assistant Professor : Researcher - Pain Specialist - Neurosurgeon

St Joseph University, Beirut, Lebanon

研究点 (1)

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