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
- Osteoarthritis, knee replacement surgery, inguinal hernia, inguinal hernia surgery.
- Registration Number
- NL-OMON20334
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 540
1. Patients scheduled for elective inguinal hernia surgery(270) or knee replacement surgery (270)
2. American Society of Anesthesiologists score 1, 2 or 3
3. Age between 18-80 years
1. Pain scores > 3 (on a 11-point numerical rating scale, NRS) reported for most of the day during the past month (except for knee pain in patients planned for knee replacement surgery);
2. Regular use of anti-depressants or anti-epileptics for any purpose, including SNRIs and gabapentinoids
3. Known allergies or contraindication to the study medication according to the SmPC
4. The presence of any chronic pain disorder (other than chronic knee pain);
5. Pregnancy/lactation;
6. Use of MAO-inhibitors or rifampicin within the last 14 days before inclusion;
7. Inability to perform psychophysical testing
8. Inability to give informed consent;
9. Inability to communicate with the investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Both CPM and the presence of central sensitization (measured by TS and allodynia) will be measured before and after treatment to evaluate the effect of Tapentadol on these responses.
- Secondary Outcome Measures
Name Time Method 1. The effect of Tapentadol compared to placebo on acute postoperative pain in pa-tients planned for elective inguinal hernia surgery and knee replacement surgery.<br>2. The influence of the pre-operative pain profile (inhibitory as measured by CPM and facilitatory as measured by the presence of central sensitization) on the de-velopment of chronic postoperative pain in patients with and without chronic pain in the pre-operative phase.<br>3. The influence of Tapentadol and placebo on the individual pain profiles (inhibitory as measured by CPM and facilitatory as measured by the presence of central sensitization) and its influence on the development of chronic postoperative pain.