Clinical trial NCT01902108: Added Value of Local Clonidine for Spine Postoperative Pain Control, in Addition to Bupivacaine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Pain
Keywords: clonidine
bupivacaine
post-operative pain
arthrodesis
discectomy
local infiltration
Lead sponsor: St Joseph University, Beirut, Lebanon
Sponsor class: OTHER
First posted: 2013-07-18
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Area under curve
timeFrame: From the day of surgery till the 8th postoperative day (9 days and 8 nights=200h
Secondary outcomes:
measure: Area under Curve (AUC) of pain
timeFrame: Calculated at Day 0-2, Day3-5, Day6-8 and all along the follow-up from Day0 till Day8
measure: Daily rescue opiates consumption
timeFrame: From the day of surgery till the 3rd postoperative day
measure: Global subjective patient satisfaction of post-operative wound pain control
timeFrame: Assessed at the end of follow-up on Day 8
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hotel Dieu de france Hospital
Study officials:
affiliation: Laboratory of neurosciences, Faculty of medicine, St Joseph University of Beirut
name: Joseph Maarrawi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdel Hay J, Kobaiter-Maarrawi S, Tabet P, Moussa R, Rizk T, Nohra G, Okais N, Samaha E, Maarrawi J. Bupivacaine Field Block With Clonidine for Postoperative Pain Control in Posterior Spine Approaches: A Randomized Double-Blind Trial. Neurosurgery. 2018 Jun 1;82(6):790-798. doi: 10.1093/neuros/nyx313.