This study has been transitioned to CTIS with ID 2024-511010-21-00 check the CTIS register for the current data. To prevent the development of chronic postoperative pain after inguinal hernia surgery and knee replacement surgery and to to further…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Chronische pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect of tapentadol compared to placebo on the development of chronic pain
in the first year after surgery
Secondary outcome
1. The effect of Tapentadol compared to placebo on acute postoperative pain in
patients 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 development 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
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.
Study objective
This study has been transitioned to CTIS with ID 2024-511010-21-00 check the CTIS register for the current data.
To prevent the development of chronic postoperative pain after inguinal hernia
surgery and knee replacement surgery and to to further explore the mechanism
behind the development of chronic postoperative pain.
Study design
A double-blind, randomized, placebo-controlled, non-crossover longitudinal
study.
Intervention
Postoperative treatment with oral tapentadol sustained release (maximum of 100
mg twice daily) and placebo.
Study burden and risks
The risk for the patients in the current study are minimal. Patients will be
asked to use extra medication (outside the standard of care) for a period of 4
weeks. Most important side effects of the study medication are dizziness and
somnolence. In case of unacceptable side effects the dose can be lowered during
the study period.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
1. Patients scheduled for elective inguinal hernia surgery or knee replacement
surgery (to assess the severity of the knee osteoarthritis the Kellgren and
Lawrance criteria will be used; see appendix 1).
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
(such as the presence of respiratory depression, severe astma, paralytic ileus
and acute intoxications with alcohol, hypnotics or other psychotropic active
substances); 4. The presence of any chronic pain disorder; 5.
Pregnancy/lactation; 6. Use of MAO-inhibitors or rifampicin within the last 14
days before inclusion; 7. Inability to perform psychophysical testing (eg. in
case of cognitive or psychiatric disorders); 8. Inability to give informed
consent; 9. Inability to communicate with the investigators.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-511010-21-00 |
| EudraCT | EUCTR2018-004804-21-NL |
| CCMO | NL68622.058.18 |