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The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery

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ClinicalTrials.gov Identifier: NCT01933542
Recruitment Status : Completed
First Posted : September 2, 2013
Last Update Posted : September 17, 2015
Sponsor:
Collaborator:
Glostrup University Hospital, Copenhagen
Information provided by (Responsible Party):
Rikke Vibeke Nielsen, MD, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Chlorzoxazone Postoperative Pain Drug: Placebo Drug: Chlorzoxazone Drug: Morphine Drug: Zofran Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery
Study Start Date : August 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: Chlorzoxazone
Two 250 mg chlorzoxazone tablets

Drug: Morphine
Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.

Drug: Zofran
Zofran 4 mg iv. in case of moderate to severe nausea, supplemented by Zofran 1 mg iv. if needed

Placebo Comparator: 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
Drug: Placebo
Two placebo tablets identical to the chlorzoxazone tablets.

Drug: Morphine
Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.

Drug: Zofran
Zofran 4 mg iv. in case of moderate to severe nausea, supplemented by Zofran 1 mg iv. if needed




Primary Outcome Measures :
  1. Painscore during mobilization [ Time Frame: 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 Outcome Measures :
  1. Morphine consumption [ Time Frame: 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).

  2. Painscore during rest [ Time Frame: 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.

  3. Painscore during mobilization [ Time Frame: 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.

  4. Degree of nausea [ Time Frame: 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.

  5. Zofran consumption [ Time Frame: 4 hours after taking the trial medication ]
    Consumption of Zofran (milligram) 0-4 hours after taking the trial medication.

  6. Degree of dizziness [ Time Frame: 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.

  7. Incidence of vomiting [ Time Frame: 0-4 hours after taking the trial medication ]
    Total number of vomits 0-4 hours after taking the trial medication.

  8. Degree of sedation [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933542


Locations
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Denmark
Glostrup University Hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
Rigshospitalet, Denmark
Glostrup University Hospital, Copenhagen
Investigators
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Principal Investigator: Rikke Soennichsen, MD Glostrup University Hospital

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Responsible Party: Rikke Vibeke Nielsen, MD, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01933542     History of Changes
Other Study ID Numbers: SM2-RS-2013
First Posted: September 2, 2013    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015
Keywords provided by Rikke Vibeke Nielsen, MD, Rigshospitalet, Denmark:
Chlorzoxazone
Postoperative pain
Spine surgery
Opioid consumption
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Ondansetron
Chlorzoxazone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Anti-Anxiety Agents
Muscle Relaxants, Central