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
Overview
- Phase
- Phase 4
- Intervention
- Clonidine
- Conditions
- Post-operative Pain
- Sponsor
- St Joseph University, Beirut, Lebanon
- Enrollment
- 225
- Locations
- 1
- Primary Endpoint
- Mean Area under curve
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Dr Joseph Maarrawi
Assistant Professor : Researcher - Pain Specialist - Neurosurgeon
St Joseph University, Beirut, Lebanon
Eligibility Criteria
Inclusion Criteria
- •First (not recurrent) posterior spinal surgery at the operated site
- •American Society of Anesthesiologists class I or II (operative risk)
Exclusion Criteria
- •Allergy to local anesthetics or to clonidine
- •Pregnancy
- •Raynaud's syndrome
- •Thromboangiitis obliterans
- •History of substance abuse
- •Current treatment with corticosteroids
Arms & Interventions
Clonidine
Clonidine 150μg added to bupivacaine in a local infiltration before wound incision
Intervention: Clonidine
Bupivacaine
Bupivacaine 0.25 % alone in the wound infiltration
Intervention: Bupivacaine
Outcomes
Primary Outcomes
Mean Area under curve
Time Frame: 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.
Secondary Outcomes
- 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)