The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery
Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chlorzoxazone; Postoperative Pain
Intervention: Placebo (Drug); Chlorzoxazone (Drug); Morphine (Drug); Zofran (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Rigshospitalet, Denmark Official(s) and/or principal investigator(s): Rikke Soennichsen, MD, Principal Investigator, Affiliation: Glostrup University Hospital
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.
Clinical Details
Official title: The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Painscore during mobilization
Secondary outcome: Morphine consumptionPainscore during rest Painscore during mobilization Degree of nausea Zofran consumption Degree of dizziness Incidence of vomiting Degree of sedation
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Glostrup University Hospital, Glostrup 2600, Denmark; Recruiting Rikke Soennichsen, MD, Phone: 004560926839, Email: rikkesoennichsen@gmail.com Rikke Soennichsen, MD, Principal Investigator
Additional Information
Starting date: August 2013
Last updated: August 18, 2015
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