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Completed

NCT Number: NCT01933542

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

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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Key information

Conditions

Chlorzoxazone Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Glostrup University Hospital

Glostrup Municipality, Glostrup, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Two placebo tablets identical to the chlorzoxazone tablets.

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Glostrup University Hospital, Copenhagen

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 2, 2013
Registry last updated
Sep 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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