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

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

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: Clonidine; Drug: Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 16-6830
    • Hotel Dieu de France Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: St Joseph University, Beirut, Lebanon
• Investigators: Principal Investigator: Joseph Maarrawi, MD, PhD, Laboratory of neurosciences, Faculty of medicine, St Joseph University of Beirut

Publications and helpful links

General Publications

• Abdel Hay J, Kobaiter-Maarrawi S, Tabet P, Moussa R, Rizk T, Nohra G, Okais N, Samaha E, Maarrawi J. Bupivacaine Field Block With Clonidine for Postoperative Pain Control in Posterior Spine Approaches: A Randomized Double-Blind Trial. Neurosurgery. 2018 Jun 1;82(6):790-798. doi: 10.1093/neuros/nyx313.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 7, 2013
• First Submitted That Met QC Criteria: July 17, 2013
• First Posted (Estimate): July 18, 2013

Study Record Updates

• Last Update Posted (Estimate): December 8, 2015
• Last Update Submitted That Met QC Criteria: December 6, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: bupivacaine; arthrodesis; local infiltration; clonidine; post-operative pain; discectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Sympatholytics; Bupivacaine; Clonidine
• Other Study ID Numbers: CLON-POBPC