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

Primary Purpose

Chlorzoxazone, Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Placebo
Chlorzoxazone
Morphine
Zofran
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chlorzoxazone focused on measuring Chlorzoxazone, Postoperative pain, Spine surgery, Opioid consumption

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Glostrup University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Chlorzoxazone

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Painscore during mobilization
Painscore during active mobilization (VAS scale) defined by a standarized movement from recumbent position to sitting on the bedside

Secondary Outcome Measures

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).
Painscore during rest
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
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
Degree of nausea 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.
Degree of dizziness
Degree of dizziness 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.
Degree of sedation
Degree of sedation 1, 2, 3 and 4 hours after taking the trial medication.

Full Information

First Posted
August 23, 2013
Last Updated
September 16, 2015
Sponsor
Rigshospitalet, Denmark
Collaborators
Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01933542
Brief Title
The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery
Official Title
The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlorzoxazone, Postoperative Pain
Keywords
Chlorzoxazone, Postoperative pain, Spine surgery, Opioid consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorzoxazone
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two placebo tablets identical to the chlorzoxazone tablets.
Intervention Type
Drug
Intervention Name(s)
Chlorzoxazone
Intervention Description
Two 250 mg chlorzoxazone tablets
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
Intervention Type
Drug
Intervention Name(s)
Zofran
Intervention Description
Zofran 4 mg iv. in case of moderate to severe nausea, supplemented by Zofran 1 mg iv. if needed
Primary Outcome Measure Information:
Title
Painscore during mobilization
Description
Painscore during active mobilization (VAS scale) defined by a standarized movement from recumbent position to sitting on the bedside
Time Frame
2 hours after taking the trial medication
Secondary Outcome Measure Information:
Title
Morphine consumption
Description
Total morphine consumption 0-4 hours after taking the trial medication, administered as patient controlled analgesia (PCA, bolus 2.5 mg, lockout 10 minutes).
Time Frame
0-4 hours after taking the trial medication
Title
Painscore during rest
Description
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.
Time Frame
1, 2, 3 and 4 hours after taking the trial medication
Title
Painscore during mobilization
Description
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.
Time Frame
1, 2, 3 and 4 hours after taking the trial medication
Title
Degree of nausea
Description
Degree of nausea 1, 2, 3 and 4 hours after taking the trial medication.
Time Frame
1, 2, 3 and 4 hours after taking the trial medication
Title
Zofran consumption
Description
Consumption of Zofran (milligram) 0-4 hours after taking the trial medication.
Time Frame
4 hours after taking the trial medication
Title
Degree of dizziness
Description
Degree of dizziness 1, 2, 3 and 4 hours after taking the trial medication.
Time Frame
1, 2, 3 and 4 hours after taking the trial medication
Title
Incidence of vomiting
Description
Total number of vomits 0-4 hours after taking the trial medication.
Time Frame
0-4 hours after taking the trial medication
Title
Degree of sedation
Description
Degree of sedation 1, 2, 3 and 4 hours after taking the trial medication.
Time Frame
1, 2, 3 and 4 hours after taking the trial medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rikke Soennichsen, MD
Organizational Affiliation
Glostrup University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glostrup University Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

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

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