NCT01933542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

2 years

First QC Date

August 23, 2013

Last Update Submit

September 16, 2015

Conditions

ChlorzoxazonePostoperative Pain

Keywords

ChlorzoxazonePostoperative painSpine surgeryOpioid consumption

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Morphine consumption

    0-4 hours after taking the trial medication

  • Painscore during rest

    1, 2, 3 and 4 hours after taking the trial medication

  • Painscore during mobilization

    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

  • Zofran consumption

    4 hours after taking the trial medication

  • +3 more secondary outcomes

Study Arms (2)

Chlorzoxazone

ACTIVE COMPARATOR

* 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: ChlorzoxazoneDrug: MorphineDrug: Zofran

Placebo

PLACEBO COMPARATOR

* 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: PlaceboDrug: MorphineDrug: Zofran

Interventions

PlaceboDRUG

Two placebo tablets identical to the chlorzoxazone tablets.

Placebo
ChlorzoxazoneDRUG

Two 250 mg chlorzoxazone tablets

Chlorzoxazone
MorphineDRUG

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

ChlorzoxazonePlacebo
ZofranDRUG

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

ChlorzoxazonePlacebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing spine surgery in general anaesthesia.
  • Postoperative pain \> 50 mm on the VAS scale during mobilization.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup University Hospital

Glostrup Municipality, Glostrup, 2600, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

ChlorzoxazoneMorphineOndansetron

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BenzoxazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingCarbazolesIndolesHeterocyclic Compounds, 3-Ring

Study Officials

  • Rikke Soennichsen, MD

    Glostrup University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 23, 2013

First Posted

September 2, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations

DK(1)