The effect of the substance Klorzoxazon as pain after back surgery

The effect of chlorzoxazone of moderate to severe postoperative pain after back surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002247-28-DK

Enrollment

Unknown

Registered

2013-07-04

Start date

2013-07-04

Completion date

Unknown

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients set to back surgery in general anesthesia MedDRA version: 16.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865

Interventions

Trade Name: Chlorzoxazon Product Name: Chlorzoxason Pharmaceutical Form: Tablet INN or Proposed INN: CHLORZOXAZONE CAS Number: 95-25-0 Other descriptive name: Chlorzoxazon Concentration unit: mg milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patient has undergone back surgery in general anesthesia Postoperative VAS score of active mobilization defined by standardized movement from supine to sitting on the edge of the bed> 50 mm, measured on awakening or ward Have not received pain medication one hour prior to study entry Age> 18 and 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: Participation in other drug trials • Patients who can not understand or speak Danish. • Women of childbearing age with positive urine HCG pregnancy test. • Allergy to those used in the study drugs. • Alcohol and / or drug abuse - the investigator's opinion. • Daily consumption of strong opioids (morphine, ketogan, Oxynorm, methadone, fentanyl) • Fixed chlorzoxazone treatment. • Known or suspected porphyria

Design outcomes

Primary

Measure	Time frame
Main Objective: Our purpose is to investigate the effect of chlorzoxazone of moderate to severe postoperative pain after spine surgery. Our hypothesis is that chlorzoxazone may reduce postoperative pain, as well as reduce opioidforbrug and adverse reactions compared to placebo.;Secondary Objective: Not applicable;Primary end point(s): Pain Score of active mobilization (VAS) defined by standardized movement from supine to sitting on the edge of the bed on time 2 hours after the intake of chlorzoxazone.;Timepoint(s) of evaluation of this end point: 2 hours after intake of studymedication	—

Measure

Time frame

Main Objective: Our purpose is to investigate the effect of chlorzoxazone of moderate to severe postoperative pain after spine surgery. Our hypothesis is that chlorzoxazone may reduce postoperative pain, as well as reduce opioidforbrug and adverse reactions compared to placebo.;Secondary Objective: Not applicable;Primary end point(s): Pain Score of active mobilization (VAS) defined by standardized movement from supine to sitting on the edge of the bed on time 2 hours after the intake of chlorzoxazone.;Timepoint(s) of evaluation of this end point: 2 hours after intake of studymedication

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Secondary

Measure	Time frame
Secondary end point(s): The total need for morphine from 0 to 4 hours after administration of the studymedication administered as patient-controlled pain management (PCA bolus 2.5 mg, lockout 10 minutes) and escape morphine. Pain Score at rest (VAS) at time 1, 2, 3 and 4 hours, calculated as the area under the curve (AUC) from 1-4 hours after intake of studymedication. Pain Score of active mobilization (VAS) defined by a standardized movement from supine to sitting on the edge of the bed on time 1, 2, 3 and 4 hours, calculated area under the curve from 1-4 hours after intake of studymedication . The degree of nausea at time 1, 2, 3 and 4 hours after intake of study medication. The degree of dizziness at time 1, 2, 3 and 4 hours after taking the medicine project Number of vomiting during the periods 0-4 hours after intake of studymedication. consumption of Zofran over the period 0-4 hours after intake of study medication. Degree of sedation at time 1, 2, 3 and 4 hours after intake of study medication. ;Timepoint(s) of evaluation of this end point: 1,2,3 and 4 hours after intake of study medication	—

Measure

Time frame

Secondary end point(s): The total need for morphine from 0 to 4 hours after administration of the studymedication administered as patient-controlled pain management (PCA bolus 2.5 mg, lockout 10 minutes) and escape morphine. Pain Score at rest (VAS) at time 1, 2, 3 and 4 hours, calculated as the area under the curve (AUC) from 1-4 hours after intake of studymedication. Pain Score of active mobilization (VAS) defined by a standardized movement from supine to sitting on the edge of the bed on time 1, 2, 3 and 4 hours, calculated area under the curve from 1-4 hours after intake of studymedication . The degree of nausea at time 1, 2, 3 and 4 hours after intake of study medication. The degree of dizziness at time 1, 2, 3 and 4 hours after taking the medicine project Number of vomiting during the periods 0-4 hours after intake of studymedication. consumption of Zofran over the period 0-4 hours after intake of study medication. Degree of sedation at time 1, 2, 3 and 4 hours after intake of study medication. ;Timepoint(s) of evaluation of this end point: 1,2,3 and 4 hours after intake of study medication

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Countries

Denmark

Contacts

Public ContactDepartment of Anaesthesia 4231

Rigshospitalet

joergen.berg.dahl@regionh.dk+4535 4595 02

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026