Chlorzoxazone, Postoperative Pain
Conditions
Keywords
Chlorzoxazone, Postoperative pain, Spine surgery, Opioid consumption
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.
Interventions
DRUGPlacebo
Two placebo tablets identical to the chlorzoxazone tablets.
DRUGChlorzoxazone
Two 250 mg chlorzoxazone tablets
DRUGMorphine
Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
DRUGZofran
Zofran 4 mg iv. in case of moderate to severe nausea, supplemented by Zofran 1 mg iv. if needed
Sponsors
Glostrup University Hospital, Copenhagen
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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. |
| Zofran consumption | 4 hours after taking the trial medication | Consumption of Zofran (milligram) 0-4 hours after taking the trial medication. |
Countries
Denmark
Outcome results
None listed