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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2025-12-22

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

CHU AMIENS-PICARDIE

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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

Secondary objectives 9

1. Quality of recovery at 48 and 72 hours postoperatively, assessed using the QoR-15 (Quality of Recovery-15) scale
2. Postoperative pain intensity, assessed on an 11-point Numerical Rating Scale (NRS 0–10) in the Post-Anesthesia Care Unit (PACU), and at 24, 48, and 72 hours
3. Postoperative opioid consumption at 24 and 72 hours
4. Analgesic efficacy following opioid administration
5. Length of stay in the PACU and total length of hospital stay
6. Incidence of opioid-related adverse events within 72 hours postoperatively
7. Patient satisfaction with pain management at the end of hospitalization
8. Opioid consumption at 1 and 3 months post-surgery, and assessment of misuse risk in case of continued use
9. Incidence of chronic postoperative pain at 3 months after surgery

Conditions and MedDRA coding

Postoperative pain following scheduled major laparoscopic abdominal surgery

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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

Exclusion criteria 12

1. Allergy or intolerance to any of the following medications: paracetamol, nefopam, ketoprofen, tramadol, morphine, sufentanil, lidocaine, propofol, ketamine, dexamethasone, or droperidol
2. 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
3. Chronic use of monoamine oxidase inhibitors or CYP2D6 inhibitors
4. Chronic preoperative use of level 2 or 3 analgesics
5. Outpatient surgery
6. Surgery requiring postoperative admission to an intensive care unit (ICU)
7. Patient on long-term oxygen therapy
8. Patient with psychiatric disorders
9. Patient with neurodegenerative diseases
10. Patient unable to self-assess pain using a numerical rating scale (0–10) (e.g., due to language barrier)
11. Pregnant or breastfeeding women
12. Patient under legal guardianship, legal protection, or deprived of liberty

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the multidimensional score validated in French assessing postoperative patient recovery: the QoR-15 (Quality of Recovery-15) score at 24 hours after surgery.

Secondary endpoints 10

1. QoR-15 questionnaire scores at 48 and 72 hours
2. Mean postoperative pain NRS (0–10) scores in the Post-Anesthesia Care Unit (PACU), and at 24, 48, and 72 hours
3. Opioid consumption expressed in oral morphine equivalent at 24 and 72 hours postoperatively
4. Analgesic efficacy after opioid administration, assessed by NRS (0–10) two hours post opioid administration
5. Length of stay in the PACU (minutes) and total postoperative hospital stay (days)
6. Occurrence of the following adverse effects after opioid use: nausea/vomiting, ileus, hypoxemia, pruritus, confusion (assessed by CAM tool)
7. Pain management satisfaction score, evaluated on a numerical scale from 0 to 10 (0 = total dissatisfaction, 10 = total satisfaction) at hospital discharge
8. Number of patients consuming opioids daily at 1 and 3 months post-discharge
9. Misuse risk assessment using the POMI-5F scale
10. Presence of chronic post-surgical pain at 3 months after surgery

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Amiens Picardie

Sponsor organisation

Centre Hospitalier Universitaire Amiens Picardie

Address

1 Rond Point Du Pr Christian Cabrol

City

Amiens Cedex 1

Postcode

80054

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

Justine ROUSSEAUX

Public contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

Justine ROUSSEAUX

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications