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ID
Source
Brief title
Health condition
Osteoarthritis, knee replacement surgery, inguinal hernia, inguinal hernia surgery.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
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.
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.
Background summary
Rationale: The development of chronic postoperative pain is not well understood. We recently conducted a large trial in patients who underwent inguinal hernia surgery and investigated whether the pre-operative state of the endogenous pain modulatory system (a central pain modulatory system important for normal pain perception) could predict the development of postoperative chronic pain after inguinal hernia surgery. In this study we demonstrated that a normal functioning endogenous pain modulatory system was predictive for the development of postoperative chronic pain. Tapentadol is an analgesic able to influence the endogenous pain system by maintaining its function and we hypothesize that treatment with tapentadol will reduce the change to develop postoperative chronic pain.
Objective: 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.
Study design: A double-blind, randomized, placebo-controlled, non-crossover longitudinal study.
Study population: Patients planned for elective inguinal hernia surgery or knee replacement surgery.
Intervention (if applicable): Postoperative treatment with oral tapentadol sustained release (maximum of 100 mg twice daily) and placebo.
Main study parameters/endpoints: (1) The effect of tapentadol compared to placebo on the development of chronic pain in the first year after surgery; (2) The influence of the pre-operative pain profile on the development of chronic postoperative pain and (3) The influence of tapentadol and placebo on the individual pain profiles and its influence on the development of chronic postoperative pain.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for the patients is that they will take low doses of pain medication for 1 month after surgery and will come to the hospital 2 times for pain testing and questionnaires. The hospital visit will take about 30-45 minutes.
Study objective
We hypothesize that treatment with Tapentadol will reduce the development of chronic postoperative pain by enhancing or maintaining CPM responses and possibly reducing central sensitization. We hypothesize that a 4-week treatment with Tapentadol will reduce the risk for these patients to develop chronic postoperative pain in the first year after surgery.
Study design
After the treatment period the development of chronic pain will be assessed by telephone at 3, 6 and 12 months after the surgery. Pain intensity will be assessed using the numerical rating scale (NRS) and patients will be asked to fill in a pain diary every month where they score the average pain score during rest and during exercise in the last month and last week.
Intervention
Tapentadol or placebo for a 4-week period
Marieke Niesters
Phone: +31 (0)71 5262301
m.niesters@lumc.nl
Marieke Niesters
Phone: +31 (0)71 5262301
m.niesters@lumc.nl
Inclusion criteria
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
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9223 |
| Other | METC LDD : P20.084 |