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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01902108
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : December 8, 2015
Information provided by (Responsible Party):
Dr Joseph Maarrawi, St Joseph University, Beirut, Lebanon

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Mean Area under curve [ Time Frame: 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 :
  1. Area under Curve (AUC) of pain [ Time Frame: 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

  2. Daily rescue opiates consumption [ Time Frame: 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.

  3. Global subjective patient satisfaction of post-operative wound pain control [ Time Frame: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01902108

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Hotel Dieu de france Hospital
Beirut, Lebanon, 16-6830
Sponsors and Collaborators
St Joseph University, Beirut, Lebanon
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Principal Investigator: Joseph Maarrawi, MD, PhD Laboratory of neurosciences, Faculty of medicine, St Joseph University of Beirut
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Joseph Maarrawi, Assistant Professor : Researcher - Pain Specialist - Neurosurgeon, St Joseph University, Beirut, Lebanon Identifier: NCT01902108    
Other Study ID Numbers: CLON-POBPC
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Keywords provided by Dr Joseph Maarrawi, St Joseph University, Beirut, Lebanon:
post-operative pain
local infiltration
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action