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(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
EU CTIS ID: 2024-511010-21-00
What this study is testing
To prevent the development of chronic postoperative pain after inguinal hernia surgery and knee replacement surgery and to further explore the mechanism behind the development of chronic postoperative pain
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- American Society of Anesthesiologists score 1, 2 or 3
- Age between 18-80 years
You likely can't join if
- 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
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.