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

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20334

Enrollment

540

Registered

2021-01-27

Start date

2021-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, knee replacement surgery, inguinal hernia, inguinal hernia surgery.

Interventions

Tapentadol or placebo for a 4-week period

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactMarieke Niesters

Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600 Albinusdreef 2 2300 RC Leiden The Netherlands

m.niesters@lumc.nlPhone: +31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)