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 Details — Status: Completed

Administrative data

• NCT number: NCT01902108
• Other study ID #: CLON-POBPC
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2013
• Last updated: December 6, 2015
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: St Joseph University, Beirut, Lebanon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lebanon: Ministry of Public Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 72 Years

Eligibility

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

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

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• Bupivacaine
Local infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone
• Clonidine
Clonidine 150µg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision

Locations

Country	Name	City	State
Lebanon	Hotel Dieu de france Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
St Joseph University, Beirut, Lebanon

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Area under curve	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.	From the day of surgery till the 8th postoperative day (9 days and 8 nights=200h	No
Secondary	Area under Curve (AUC) of pain	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	Calculated at Day 0-2, Day3-5, Day6-8 and all along the follow-up from Day0 till Day8	No
Secondary	Daily rescue opiates consumption	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.	From the day of surgery till the 3rd postoperative day	No
Secondary	Global subjective patient satisfaction of post-operative wound pain control	It may vary from 0 that means a total dissatisfaction to 100% that means a complete satisfaction	Assessed at the end of follow-up on Day 8	No