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. - Prevent

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52388

Enrollment

540

Registered

2019-11-19

Start date

2020-11-09

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Chronische pijn Chronic pain

Interventions

Postoperative treatment with oral tapentadol sustained release (maximum of 100 mg twice daily) and placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The effect of tapentadol compared to placebo on the development of chronic pain in the first year after surgery	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)