Post-operative Pain | Added Value of Local Clonidine for Spine Postoperative Pain Control, in Addition to Bupivacaine
Post-operative Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:BupivacaineLocal infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone
Drug:ClonidineClonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ClonidineClonidine 150μg added to bupivacaine in a local infiltration before wound incision
BupivacaineBupivacaine 0.25 % alone in the wound infiltration
Start Date: January 2013
Completed Date: December 2015
Phase: Phase 4
Primary Outcome: Mean Area under curve
Secondary Outcome: Area under Curve (AUC) of pain
Study sponsors, principal investigator, and references
Principal Investigator: Joseph Maarrawi, MD, PhD
Lead Sponsor: St Joseph University, Beirut, Lebanon