The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery
NCT ID: NCT01933542
Last Updated: 2015-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
110 participants
INTERVENTIONAL
2013-08-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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
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
Placebo
Two placebo tablets identical to the 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Glostrup University Hospital, Copenhagen
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Rikke Vibeke Nielsen, MD
MD
Principal Investigators
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Rikke Soennichsen, MD
Role: PRINCIPAL_INVESTIGATOR
Glostrup University Hospital
Locations
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Glostrup University Hospital
Glostrup Municipality, Glostrup, Denmark
Countries
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Other Identifiers
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SM2-RS-2013
Identifier Type: -
Identifier Source: org_study_id
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