ChlorzoxazonePhase 4NCT01933542
The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery
A Phase 4 study testing Chlorzoxazone, Morphine and Zofran in people with Chlorzoxazone and Postoperative Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chlorzoxazone, Postoperative Pain
- What is being tested?
- Chlorzoxazone, Morphine and Zofran
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Glostrup University Hospital
Glostrup Municipality, Glostrup, 2600
About this study
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.
- Conditions
- Chlorzoxazone, Postoperative Pain
- Being tested
- Placebo, Chlorzoxazone, Morphine, Zofran
- Keywords
- Chlorzoxazone, Postoperative pain, Spine surgery, Opioid consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Two placebo tablets identical to the chlorzoxazone tablets.
ChlorzoxazoneDrug
Two 250 mg chlorzoxazone tablets
MorphineDrug
Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
ZofranDrug
Zofran 4 mg iv. in case of moderate to severe nausea, supplemented by Zofran 1 mg iv. if needed
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Chlorzoxazone; Drug: Morphine; Drug: 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 Receives: Drug: Placebo; Drug: Morphine; Drug: Zofran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Painscore during mobilization
Painscore during active mobilization (VAS scale) defined by a standarized movement from recumbent position to sitting on the bedside
Measured: 2 hours after taking the trial medication
Secondary outcomes (8)
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).
Measured: 0-4 hours after taking the trial medication
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 hours after taking the trial medication
Degree of dizziness
Degree of dizziness 1, 2, 3 and 4 hours after taking the trial medication.
Measured: 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.
Measured: 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.
Measured: 1, 2, 3 and 4 hours after taking the trial medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChlorzoxazoneStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Responsible party
- Principal investigator, Rikke Vibeke Nielsen, MD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Rikke Soennichsen, MD, Principal investigator, Glostrup University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933542
- Sponsor's protocol ID
- SM2-RS-2013
- Status last verified
- Sep 2015
- First submitted
- 23 Aug 2013
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery
- ClinicalTrials.gov ID
- NCT01933542
- Acronym / sponsor ID
- SM2-RS-2013
- Conditions
- Chlorzoxazone, Postoperative Pain
- Keywords
- Chlorzoxazone, Postoperative pain, Spine surgery, Opioid consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorzoxazone | Active comparator | Drug: Chlorzoxazone, Drug: Morphine, Drug: Zofran* 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 |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Morphine, Drug: Zofran* 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTwo placebo tablets identical to the chlorzoxazone tablets. | Drug | Placebo |
| ChlorzoxazoneTwo 250 mg chlorzoxazone tablets | Drug | Chlorzoxazone |
| MorphinePatient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml. | Drug | Chlorzoxazone, Placebo |
| ZofranZofran 4 mg iv. in case of moderate to severe nausea, supplemented by Zofran 1 mg iv. if needed | Drug | Chlorzoxazone, Placebo |
Primary outcome
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
8 secondary outcomes
Morphine consumption
Time frame: 0-4 hours after taking the trial medication
Painscore during rest
Time frame: 1, 2, 3 and 4 hours after taking the trial medication
Painscore during mobilization
Time frame: 1, 2, 3 and 4 hours after taking the trial medication
Degree of nausea
Time frame: 1, 2, 3 and 4 hours after taking the trial medication
Zofran consumption
Time frame: 4 hours after taking the trial medication
Degree of dizziness
Time frame: 1, 2, 3 and 4 hours after taking the trial medication
Incidence of vomiting
Time frame: 0-4 hours after taking the trial medication
Degree of sedation
Time frame: 1, 2, 3 and 4 hours after taking the trial medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rikke Soennichsen, MD principal investigator
Glostrup University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorzoxazone, Morphine and Zofran in people with Chlorzoxazone and Postoperative Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Painscore during mobilization (time frame: 2 hours after taking the trial medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2015.