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

Sponsor

St Joseph University, Beirut, Lebanon (Other)

Overall Status

Completed

CT.gov ID

NCT01902108

Collaborator

(none)

225

Enrollment

Location

Arms

Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-operative Pain	Drug: Bupivacaine Drug: Clonidine	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

225 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clonidine Clonidine 150μg added to bupivacaine in a local infiltration before wound incision	Drug: Clonidine Clonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision
Active Comparator: Bupivacaine Bupivacaine 0.25 % alone in the wound infiltration	Drug: Bupivacaine Local infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone

Arm

Intervention/Treatment

Experimental: Clonidine

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

Drug: Clonidine

Clonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision

Active Comparator: Bupivacaine

Bupivacaine 0.25 % alone in the wound infiltration

Drug: Bupivacaine

Local infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone

Outcome Measures

Primary Outcome Measures

Mean Area under curve [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 Outcome Measures

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]
The AUC during an interval (in days) is calculated by adding the different values of pain assessed during day and night multiplied by the duration (in hours) of sufferance from this amount of pain. The AUC during an interval is proportional to the mean intensity of pain suffered during the same interval. It is expressed in pain unit multiplied by hour
Daily rescue opiates consumption [From the day of surgery till the 3rd postoperative day]
The unit of rescue opiates consumption equals the administration of 5mg of morphine subcutaneously. The minimum interval between 2 rescue opiates consumption is 6 hours. Thus, the rescue opiates consumption may vary from 0 to 4/day.
Global subjective patient satisfaction of post-operative wound pain control [Assessed at the end of follow-up on Day 8]
It may vary from 0 that means a total dissatisfaction to 100% that means a complete satisfaction