An observational study on 75 mg Tramadol/25 mg Dexketoprofen fixed-dose combination in the treatment of post-surgical pain in patients undergoing day surgery (SERENITY)

Study identification

• EU PAS number:
  EUPAS1000000216
• Study ID:
  1000000216
• Official title and acronym:
  An observational study on 75 mg Tramadol/25 mg Dexketoprofen fixed-dose combination in the treatment of post-surgical pain in patients undergoing day surgery (SERENITY)
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study description:
  Non-interventional, prospective, uncontrolled, and multicentre. The study will include 200 patients. Assuming approximately a 15% drop-out rate, 170 patients are expected to be evaluable. The study population will comprise adult patients (male and female, aged 18 years or older) undergoing day surgeries and managed as outpatients following hospital discharge.
• Study status:
  Planned

Research institutions and networks

Institutions

A. Menarini Farmaceutica Internazionale S.r.l.

Study timelines

Date when funding contract was signed

Actual: 01/08/2024

Study start date

Planned: 22/12/2024

Date of final study report

Planned: 22/06/2026

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable