(PREVENT)A Randomized, Double-blind, Placebo-controlled Trial on the Prevention of Chronic Postoperative Pain after Inguinal Hernia and Knee Surgery by Postoperative Treatment with Tapentadol
- Conditions
- chronic postoperative painTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2024-511010-21-00
- Lead Sponsor
- eids Universitair Medisch Centrum (LUMC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 540
American Society of Anesthesiologists score 1, 2 or 3, Age between 18-80 years
Chronic pain due to any cause other than pain caused by osteoarthritis of the knee or inguinal hernia which in the opinion of the investigator may influence the outcome of the trial;, Regular use of anti-depressants or anti-epileptics for chronic pain. If this medica-tion is used for another indication than pain participation in the study is allowed., Known allergies or contraindication to the study medication according to the SmPC (such as the presence of respiratory depression, severe astma, paralytic ileus and acute intoxications with alcohol, hypnotics or other psychotropic active substances);, Pregnancy/lactation;, Use of MAO-inhibitors or rifampicin within the last 14 days before inclusion;, Inability to perform psychophysical testing (eg. in case of cognitive or psychiatric disorders, Inability to give informed consent, Inability to communicate with the investigators
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method