The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery

Phase 4CompletedNCT01933542

Rigshospitalet, Denmark110 enrolled

Overview

Chlorzoxazone is a centrally acting muscle relaxant used to treat muscle spasm and the resulting pain or discomfort. It acts on the spinal cord by depressing reflexes. Our purpose is to investigate the effect of chlorzoxazone on moderate to severe postoperative pain after spine surgery. Our hypothesis is that chlorzoxazone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

110

Conditions

Chlorzoxazone Postoperative Pain

Interventions

PlaceboDRUG

Two placebo tablets identical to the chlorzoxazone tablets.

ChlorzoxazoneDRUG

Two 250 mg chlorzoxazone tablets

MorphineDRUG

Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing spine surgery in general anaesthesia. * Postoperative pain \> 50 mm on the VAS scale during mobilization. * Patients who have not received analgesia 1 hour prior to inclusion. * ASA 1-3. * BMI \> 18 og \< 40. * Fertile women need a negative HCG urine test. * Patients who have given their written consent to participate and understand the contents of the protocol. Exclusion Criteria: * Participation in another clinical trial. * Patients who do not speak and/or understand Danish. * Fertile women with a positive HCG urine test. * Allergy to the drugs used in the trial. * Alcohol or medicine abuse, assessed by investigator. * Daily use of strong opioids (morphine, ketobemidone, oxynorm, methadone, fentanyl) * Daily chlorzoxazone treatment. * Known or suspected porphyria.

Locations (1)

Glostrup University Hospital

Glostrup Municipality, Glostrup, Denmark

Outcomes

Primary Outcomes

Painscore during mobilization

Painscore during active mobilization (VAS scale) defined by a standarized movement from recumbent position to sitting on the bedside

Time frame: 2 hours after taking the trial medication

Secondary Outcomes

Morphine consumption

Total morphine consumption 0-4 hours after taking the trial medication, administered as patient controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes).

Time frame: 0-4 hours after taking the trial medication

Painscore during rest

Painscore at rest (VAS)at time 1, 2, 3 and 4 hours, calculated as area under curve (AUC) from 1-4 hours after taking the trial medication.

Time frame: 1, 2, 3 and 4 hours after taking the trial medication

Painscore during mobilization

Painscore during active mobilization (VAS scale) defined by a standarized movement from recumbent position to sitting on the bedside at time 1, 2, 3 and 4 hours, calculated as area under curve (AUC) from 1-4 hours after taking the trial medication.

Time frame: 1, 2, 3 and 4 hours after taking the trial medication

Degree of nausea

Degree of nausea 1, 2, 3 and 4 hours after taking the trial medication.

Time frame: 1, 2, 3 and 4 hours after taking the trial medication

Zofran consumption

Consumption of Zofran (milligram) 0-4 hours after taking the trial medication.

Time frame: 4 hours after taking the trial medication

Degree of dizziness

Degree of dizziness 1, 2, 3 and 4 hours after taking the trial medication.

Data from ClinicalTrials.gov

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