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

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Bupivacaine
Clonidine
Sponsored by
St Joseph University, Beirut, Lebanon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring clonidine, bupivacaine, post-operative pain, arthrodesis, discectomy, local infiltration

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hotel Dieu de france Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clonidine

Bupivacaine

Arm Description

Clonidine 150μg added to bupivacaine in a local infiltration before wound incision

Bupivacaine 0.25 % alone in the wound infiltration

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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

Full Information

First Posted
July 7, 2013
Last Updated
December 6, 2015
Sponsor
St Joseph University, Beirut, Lebanon
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1. Study Identification

Unique Protocol Identification Number
NCT01902108
Brief Title
Added Value of Local Clonidine for Spine Postoperative Pain Control, in Addition to Bupivacaine
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Joseph University, Beirut, Lebanon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
clonidine, bupivacaine, post-operative pain, arthrodesis, discectomy, local infiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clonidine
Arm Type
Experimental
Arm Description
Clonidine 150μg added to bupivacaine in a local infiltration before wound incision
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
Bupivacaine 0.25 % alone in the wound infiltration
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Local infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Description
Clonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision
Primary Outcome Measure Information:
Title
Mean Area under curve
Description
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.
Time Frame
From the day of surgery till the 8th postoperative day (9 days and 8 nights=200h
Secondary Outcome Measure Information:
Title
Area under Curve (AUC) of pain
Description
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
Time Frame
Calculated at Day 0-2, Day3-5, Day6-8 and all along the follow-up from Day0 till Day8
Title
Daily rescue opiates consumption
Description
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.
Time Frame
From the day of surgery till the 3rd postoperative day
Title
Global subjective patient satisfaction of post-operative wound pain control
Description
It may vary from 0 that means a total dissatisfaction to 100% that means a complete satisfaction
Time Frame
Assessed at the end of follow-up on Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Maarrawi, MD, PhD
Organizational Affiliation
Laboratory of neurosciences, Faculty of medicine, St Joseph University of Beirut
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu de france Hospital
City
Beirut
ZIP/Postal Code
16-6830
Country
Lebanon

12. IPD Sharing Statement

Citations:
PubMed Identifier
28973650
Citation
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.
Results Reference
derived

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

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