Authorised Therapeutic use (Phase IV) Postoperative pain following scheduled major laparoscopic abdominal surgery

TRAMORNOT: Tramadol versus morphine in postoperative analgesia after laparoscopic abdominal surgery: a randomized controlled trial

EU CTIS ID: 2025-523327-21-00

What this study is testing

The primary objective of this randomized controlled trial is to compare the quality of recovery at 24 hours postoperatively, assessed using the QoR-15 (Quality of Recovery-15) score, in patients receiving multimodal analgesia with either tramadol or morphine during scheduled major laparoscopic abdominal surgery

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age ≥18 years
  • Scheduled laparoscopic abdominal surgery with an expected operative duration of 2 hours or more
  • Affiliation to the national health insurance system
  • Signed informed consent to participate in the study

You likely can't join if

  • Allergy or intolerance to any of the following medications: paracetamol, nefopam, ketoprofen, tramadol, morphine, sufentanil, lidocaine, propofol, ketamine, dexamethasone, or droperidol
  • Patient unable to self-assess pain using a numerical rating scale (0–10) (e.g., due to language barrier)
  • Pregnant or breastfeeding women
  • Patient under legal guardianship, legal protection, or deprived of liberty
  • Contraindication to any of these medications (refer to the Summary of Product Characteristics): paracetamol, ketoprofen, nefopam, tramadol, morphine, sufentanil, lidocaine, propofol, ketamine, dexamethasone, or droperidol
  • Chronic use of monoamine oxidase inhibitors or CYP2D6 inhibitors
See the full eligibility criteria
Who can join
  • Age ≥18 years
  • Scheduled laparoscopic abdominal surgery with an expected operative duration of 2 hours or more
  • Affiliation to the national health insurance system
  • Signed informed consent to participate in the study
What rules you out
  • Allergy or intolerance to any of the following medications: paracetamol, nefopam, ketoprofen, tramadol, morphine, sufentanil, lidocaine, propofol, ketamine, dexamethasone, or droperidol
  • Patient unable to self-assess pain using a numerical rating scale (0–10) (e.g., due to language barrier)
  • Pregnant or breastfeeding women
  • Patient under legal guardianship, legal protection, or deprived of liberty
  • Contraindication to any of these medications (refer to the Summary of Product Characteristics): paracetamol, ketoprofen, nefopam, tramadol, morphine, sufentanil, lidocaine, propofol, ketamine, dexamethasone, or droperidol
  • Chronic use of monoamine oxidase inhibitors or CYP2D6 inhibitors
  • Chronic preoperative use of level 2 or 3 analgesics
  • Outpatient surgery
  • Surgery requiring postoperative admission to an intensive care unit (ICU)
  • Patient on long-term oxygen therapy
  • Patient with psychiatric disorders
  • Patient with neurodegenerative diseases

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.