Pain relief with klorzoxazon after incertion of a new hip or knee joint

Analgetic effect of perioperative klorzoxazon at total hip or knee arthroplasty

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001214-10-DK

Enrollment

400

Registered

2015-04-16

Start date

2015-06-02

Completion date

Unknown

Last updated

2018-03-12

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

Conditions

Perioperative pain after incertion of hip or knee arthroplasty MedDRA version: 18.0 Level: PT Classification code 10023469 Term: Knee arthroplasty System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 18.0 Level: PT Classification code 10020096 Term: Hip arthroplasty System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Klorzoxazon Pharmaceutical Form: Tablet INN or Proposed INN: CHLORZOXAZONE CAS Number: 95-25-0 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Indication for primary, cnilateral hip or knee arthroplasty Age > 18 Sex: male and female Patients with normal mental function so they are able to participate in the project. Patiens who has signed the information papers to participate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 360

Exclusion criteria

Exclusion criteria: Consumption af gabapentinoider, gluccocorticoider, opioider, anxiolytika, antiepileptika or antidrepressives within the last 4 weeks. Abuse of alkohol Need of pain treatment apart from he standard Malign condition Pregnancy og breastfeeding BMI > 40 Disease affecting the cental nerveus system Allergy towards the medicine to be tested Perioperative complications Lack of ability to walk 5 meters Liver disease

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate the effect of perioperative treatment with klorzoxazon compared to placebo. Out of need of suplementary analgentics and expierence of pain after incertion of hip or knee arthroplasty;Secondary Objective: To see how soon the patient can be mobilised after incertion of hip or knee arthroplasty;Primary end point(s): Investigate treatment with tablet klorzoxazon 250mg 3 times a day from pre-operative medication and through the first 7 days after hip or knee arthroplasty. Whether it will relief pain and increase funktion level without further side effects or not.;Timepoint(s) of evaluation of this end point: 2. postoperative day pain will be rated after walking 5 meters using VAS	—

Measure

Time frame

Main Objective: Investigate the effect of perioperative treatment with klorzoxazon compared to placebo. Out of need of suplementary analgentics and expierence of pain after incertion of hip or knee arthroplasty;Secondary Objective: To see how soon the patient can be mobilised after incertion of hip or knee arthroplasty;Primary end point(s): Investigate treatment with tablet klorzoxazon 250mg 3 times a day from pre-operative medication and through the first 7 days after hip or knee arthroplasty. Whether it will relief pain and increase funktion level without further side effects or not.;Timepoint(s) of evaluation of this end point: 2. postoperative day pain will be rated after walking 5 meters using VAS

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Data: medicaljournal, medicine accounts, patient diary and questionaires. At first examination or after 4,6,24,28,32,48 hours or after 2 to 7 days or after 14 days or 12 month depending on which questionaire is being used. ;Secondary end point(s): Pain, funktion, medication, side effects and quality of life will be rated using different questionaires at certain times. Mobility: -Oxford Hip/Knee Score 2. 4. 7. 14. postoperative day and after 12 months. Pain: -Pain VAS (0-100) at 5 meters walk 4,6,24,28,32,48 hours postoperative. 2.til 7 day and day 14 morning and evening and after 12 month -Pain VAS(0-100) after rest> 20 min. 4,6,24,28,32,48 hours postoperativt. 2.til 7 day and day 14 morning and evening and after 12 month -Kumulativ painscore for painmodalities 4 to 48 hours, 2,. and 7. day and after 12 months. -Worst pain in hip or knee within the last 24 hours. Evening 2. til 7. day and day 14 and after 12 months. -Quantitative sensory testing 12 month -Supplementary analgetica 0-28 timer og 2. til 7. døgn -Average pain while resting day and night, average pain after walking efter 30 minutes. -Pain detect -Sense of pain VAS(0-100) -Pain catastrophizing scale Quality of life: -Pittsburg slepp quality index -Sleep VAS(0-100) -Hospitality and anxiety depression scale -European questionaire in 5 dimensions Side effects: -cumulative side effect score - medicine used for sleeping og nausea -Unwanted events Other: Operations date, sex, age, weight, hight, smoking, ASA-classifikation, analgetics before operation, time for operation and use of tourniquet, bloodloss, time in hospital and intensive care after oerration, perioperative complikationer. Amount of anaestetics and other medicine.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Data: medicaljournal, medicine accounts, patient diary and questionaires. At first examination or after 4,6,24,28,32,48 hours or after 2 to 7 days or after 14 days or 12 month depending on which questionaire is being used. ;Secondary end point(s): Pain, funktion, medication, side effects and quality of life will be rated using different questionaires at certain times. Mobility: -Oxford Hip/Knee Score 2. 4. 7. 14. postoperative day and after 12 months. Pain: -Pain VAS (0-100) at 5 meters walk 4,6,24,28,32,48 hours postoperative. 2.til 7 day and day 14 morning and evening and after 12 month -Pain VAS(0-100) after rest> 20 min. 4,6,24,28,32,48 hours postoperativt. 2.til 7 day and day 14 morning and evening and after 12 month -Kumulativ painscore for painmodalities 4 to 48 hours, 2,. and 7. day and after 12 months. -Worst pain in hip or knee within the last 24 hours. Evening 2. til 7. day and day 14 and after 12 months. -Quantitative sensory testing 12 month -Supplementary analgetica 0-28 timer og 2. til 7. døgn -Average pain while resting day and night, average pain after walking efter 30 minutes. -Pain detect -Sense of pain VAS(0-100) -Pain catastrophizing scale Quality of life: -Pittsburg slepp quality index -Sleep VAS(0-100) -Hospitality and anxiety depression scale -European questionaire in 5 dimensions Side effects: -cumulative side effect score - medicine used for sleeping og nausea -Unwanted events Other: Operations date, sex, age, weight, hight, smoking, ASA-classifikation, analgetics before operation, time for operation and use of tourniquet, bloodloss, time in hospital and intensive care after oerration, perioperative complikationer. Amount of anaestetics and other medicine.

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Countries

Denmark

Contacts

Public ContactMichael Ulrich

Ortopædkirurgisk forskningsenhed

michael.ulrich@rn.dk

Outcome results

None listed

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