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Added Value of Local Clonidine for Spine Postoperative Pain Control, in Addition to Bupivacaine

Post-operative Pain Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01902108
Study type Interventional
Source St Joseph University, Beirut, Lebanon
Contact
Status Completed
Phase Phase 4
Start date January 2013
Completion date December 2015
View Details
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