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

Condition(s) targeted: Post-operative Pain

Intervention: Bupivacaine (Drug); Clonidine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: St Joseph University, Beirut, Lebanon

Official(s) and/or principal investigator(s):
Joseph Maarrawi, MD, PhD, Principal Investigator, Affiliation: Laboratory of neurosciences, Faculty of medicine, St Joseph University of Beirut

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.

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

Primary outcome: Mean Area under curve

Secondary outcome:

Area under Curve (AUC) of pain

Daily rescue opiates consumption

Global subjective patient satisfaction of post-operative wound pain control

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.

Minimum age: 18 Years. Maximum age: 72 Years. Gender(s): Both.

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

Hotel Dieu de france Hospital, Beirut 16-6830, Lebanon; Recruiting
Joseph Maarrawi, MD, PhD, Phone: 009611615300, Ext: 9513, Email: joseph.maarrawi@usj.edu.lb
Joseph Maarrawi, MD, PhD, Principal Investigator

Starting date: January 2013
Last updated: May 22, 2015