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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 consumption

Painscore 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

Page last updated: August 20, 2015

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