NCT01902108

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: St Joseph University, Beirut, Lebanon · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-operative Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine	Local infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone
DRUG	Clonidine	Clonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-07-18
• Last updated: 2015-12-08

Locations

1 site across 1 country: Lebanon