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

Phase 4

Completed

• Conditions: Chlorzoxazone; Postoperative Pain
• Interventions: Drug: Placebo; Drug: Chlorzoxazone; Drug: Morphine; Drug: Zofran

• Registration Number: NCT01933542
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-23
• Study First Submitted QC: 2013-08-30
• Study First Posted: 2013-09-02
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-16
• Last Update Posted: 2015-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	* Oral administration of two placebo tablets * Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. * Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
Chlorzoxazone	Chlorzoxazone	* Oral administration of chlorzoxazone 500 mg (two 250 mg tablets) * Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. * Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
Chlorzoxazone	Morphine	* Oral administration of chlorzoxazone 500 mg (two 250 mg tablets) * Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. * Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
Chlorzoxazone	Zofran	* Oral administration of chlorzoxazone 500 mg (two 250 mg tablets) * Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. * Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
Placebo	Morphine	* Oral administration of two placebo tablets * Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. * Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
Placebo	Zofran	* Oral administration of two placebo tablets * Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. * Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed

Primary Outcome Measures

Name	Time	Method
Painscore during mobilization	2 hours after taking the trial medication	Painscore during active mobilization (VAS scale) defined by a standarized movement from recumbent position to sitting on the bedside

Secondary Outcome Measures

Name	Time	Method
Degree of dizziness	1, 2, 3 and 4 hours after taking the trial medication	Degree of dizziness 1, 2, 3 and 4 hours after taking the trial medication.
Morphine consumption	0-4 hours after taking the trial medication	Total morphine consumption 0-4 hours after taking the trial medication, administered as patient controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes).
Painscore during rest	1, 2, 3 and 4 hours after taking the trial medication	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.
Painscore during mobilization	1, 2, 3 and 4 hours after taking the trial medication	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.
Degree of nausea	1, 2, 3 and 4 hours after taking the trial medication	Degree of nausea 1, 2, 3 and 4 hours after taking the trial medication.
Zofran consumption	4 hours after taking the trial medication	Consumption of Zofran (milligram) 0-4 hours after taking the trial medication.
Incidence of vomiting	0-4 hours after taking the trial medication	Total number of vomits 0-4 hours after taking the trial medication.
Degree of sedation	1, 2, 3 and 4 hours after taking the trial medication	Degree of sedation 1, 2, 3 and 4 hours after taking the trial medication.

Trial Locations

Locations (1)

Glostrup University Hospital; 🇩🇰 Glostrup, Denmark