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| Name | Class |
|---|---|
| Glostrup University Hospital, Copenhagen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorzoxazone | Active Comparator |
|
|
| Placebo | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Two placebo tablets identical to the chlorzoxazone tablets. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Painscore during rest |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rikke Soennichsen, MD | Glostrup University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glostrup University Hospital | Glostrup Municipality | Glostrup | 2600 | Denmark |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002753 | Chlorzoxazone |
| D009020 | Morphine |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D001583 | Benzoxazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Chlorzoxazone |
| Drug |
Two 250 mg chlorzoxazone tablets |
|
| Morphine | Drug | Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. |
|
| Zofran | Drug | Zofran 4 mg iv. in case of moderate to severe nausea, supplemented by Zofran 1 mg iv. if needed |
|
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 |
| 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 |
| 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 |
| Zofran consumption | Consumption of Zofran (milligram) 0-4 hours after taking the trial medication. | 4 hours after taking the trial medication |
| 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 |
| Incidence of vomiting | Total number of vomits 0-4 hours after taking the trial medication. | 0-4 hours after taking the trial medication |
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |