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

NCT ID: NCT01902108

Last Updated: 2015-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Post-operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Clonidine

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

Group Type EXPERIMENTAL

Clonidine

Intervention Type DRUG

Clonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision

Bupivacaine

Bupivacaine 0.25 % alone in the wound infiltration

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Local infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone

Interventions

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Bupivacaine

Local infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone

Intervention Type DRUG

Clonidine

Clonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St Joseph University, Beirut, Lebanon

OTHER

Sponsor Role lead

Responsible Party

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Dr Joseph Maarrawi

Assistant Professor : Researcher - Pain Specialist - Neurosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Maarrawi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Laboratory of neurosciences, Faculty of medicine, St Joseph University of Beirut

Locations

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Hotel Dieu de france Hospital

Beirut, , Lebanon

Site Status

Countries

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Lebanon

References

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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.

Reference Type DERIVED
PMID: 28973650 (View on PubMed)

Other Identifiers

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CLON-POBPC

Identifier Type: -

Identifier Source: org_study_id