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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?

Post-operative Pain

Study Interventions

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

Study Arms

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

Study Status

Completed

Start Date: January 2013

Completed Date: December 2015

Phase: Phase 4

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01902108

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