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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933542
• Other study ID #: SM2-RS-2013
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2013
• Last updated: September 16, 2015
• Start date: August 2013
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chlorzoxazone
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Placebo
Two placebo tablets identical to the chlorzoxazone tablets.
• Chlorzoxazone
Two 250 mg chlorzoxazone tablets
• Morphine
Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
• Zofran
Zofran 4 mg iv. in case of moderate to severe nausea, supplemented by Zofran 1 mg iv. if needed

Locations

Country	Name	City	State
Denmark	Glostrup University Hospital	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Painscore during mobilization	Painscore during active mobilization (VAS scale) defined by a standarized movement from recumbent position to sitting on the bedside	2 hours after taking the trial medication	No
Secondary	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).	0-4 hours after taking the trial medication	No
Secondary	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.	1, 2, 3 and 4 hours after taking the trial medication	No
Secondary	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.	1, 2, 3 and 4 hours after taking the trial medication	No
Secondary	Degree of nausea	Degree of nausea 1, 2, 3 and 4 hours after taking the trial medication.	1, 2, 3 and 4 hours after taking the trial medication	No
Secondary	Zofran consumption	Consumption of Zofran (milligram) 0-4 hours after taking the trial medication.	4 hours after taking the trial medication	No
Secondary	Degree of dizziness	Degree of dizziness 1, 2, 3 and 4 hours after taking the trial medication.	1, 2, 3 and 4 hours after taking the trial medication	No
Secondary	Incidence of vomiting	Total number of vomits 0-4 hours after taking the trial medication.	0-4 hours after taking the trial medication	No
Secondary	Degree of sedation	Degree of sedation 1, 2, 3 and 4 hours after taking the trial medication.	1, 2, 3 and 4 hours after taking the trial medication	No