ClinicalTrials.gg
RecruitingNCT07914335TRAMORNOTUpdated Nov 3, 2026

Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery

An interventional study of Anesthesia induction and Anesthesia maintenance in Multimodal Analgesia, Tramadol and Enhanced Recovery After Surgery, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Dec 2025, registered Oct 2026).
  • Started Dec 2025; still recruiting 10 months later.
Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Tramadol is commonly used postoperatively due to its ease of administration, but it carries several risks, including interindividual variability, drug interactions, neuropsychiatric risks in elderly patients, and long-term dependence. Although its analgesic efficacy is comparable to that of strong opioids, its role in a multimodal analgesia strategy remains insufficiently studied. Research tailored to current clinical practices is needed to accurately assess its tolerance profile.

02

Conditions studied

  • Multimodal Analgesia
  • Tramadol
  • Enhanced Recovery After Surgery
  • Opioid and Postoperative Pain

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Keywords

  • Multimodal analgesia
  • Tramadol
  • Enhanced recovery after surgery
  • Opioid and Postoperative pain
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 140 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years
  • Patient undergoing scheduled laparoscopic abdominal surgery lasting an estimated 2 hours or more.
  • Patient affiliated to the social security system.
  • Patient signature of consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Allergy or intolerance to any of the following medicines: paracetamol, nefopam, ketoprofen, tramadol, morphine, Sufentanil, lidocaine, propofol, ketamine, dexamethasone and droleptan.
  • to any of these medicines: paracetamol, ketoprofen, nefopam, tramadol, morphine, Sufentanil, lidocaine, propofol, ketamine, dexamethasone and droleptan (see Summaries of Product Characteristics).
  • Chronic use of monoamine oxidase inhibitors or CYP 450 2D6 inhibitors
  • Chronic use of level 2 or 3 analgesics preoperatively
  • Ambulatory surgery
  • Surgery requiring post-operative admission to an intensive care unit.
  • Patients on long-term oxygen therapy
  • Patients suffering from psychiatric pathologies.
  • Patient suffering from neurodegenerative pathologies
  • Patient for whom self-assessment of pain using an NRS (0-10) cannot be carried out (language barrier, etc.)
  • Pregnant or breast-feeding woman
  • Patient under guardianship or deprived of liberty.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    morphine group

    Other: Anesthesia induction · Other: Anesthesia maintenance · Other: Multimodal analgesia · Drug: Morphine

  • Active comparator
    tramadol group

    Other: Anesthesia induction · Other: Anesthesia maintenance · Other: Multimodal analgesia · Drug: Tramadol

Interventions

  • OtherAnesthesia induction

    Anesthesia induction with Propofol, Ketamine, Sufentanil, Lidocaine, and Dexamethasone

  • OtherAnesthesia maintenance

    Anesthesia maintenance with Sevoflurane, Sufentanil, and Lidocaine

  • OtherMultimodal analgesia

    Multimodal analgesia with Paracetamol, Ketoprofen, and Nefopam.

  • Morphine titration 2mg/5min if actual weight \<50kg, 3mg/5min if actual weight≥50kg if NRS≥3/10 despite administration of paracetamol, ketoprofen and nefopam in recovery room. Oral intake on return to the surgical ward with morphine 10 mg every 4 hours if actual weight ≥50 kg, 5 mg every 4 hours if weight \<50 kg, if NRS ≥3/10 despite administration of paracetamol, ketoprofen, and nefopam.

  • Tramadol: 100 mg every 6 hours if actual weight ≥50 kg, 50 mg every 6 hours if weight \<50 kg, if NRS ≥3/10 despite administration of paracetamol, ketoprofen, and nefopam Oral intake on return to the surgical ward at the same doses

06

What researchers measure

Primary outcomes

  1. Score validated in French QoR-15

    Score validated in French QoR-15

    Time frame: at 24 hours

Secondary outcomes

  1. QoR-15 questionnaire score

    QoR-15 questionnaire score

    Time frame: at 48 hours

  2. QoR-15 questionnaire score

    QoR-15 questionnaire score

    Time frame: at 72 hours

  3. Mean scores (0-10) for postoperative pain

    Mean scores (0-10) for postoperative pain in the PACU

    Time frame: at 24 hours

  4. Mean scores (0-10) for postoperative pain

    Mean scores (0-10) for postoperative pain in the PACU

    Time frame: at 48 hours

  5. Mean scores (0-10) for postoperative pain

    Mean scores (0-10) for postoperative pain in the PACU

    Time frame: at 72 hours

  6. Consumption of opioids in morphine equivalent per os

    Consumption of opioids in morphine equivalent per os

    Time frame: at 24 hours

  7. Consumption of opioids in morphine equivalent per os

    Consumption of opioids in morphine equivalent per os

    Time frame: at 72 hours

  8. Analgesic efficacy

    Analgesic efficacy after administration of an opioid assessed by NRS (0-10) 2 hours after administration of the opioid

    Time frame: 2 hours

  9. Length of stay in the postoperative intensive care unit in minutes

    Length of stay in the postoperative intensive care unit in minutes

    Time frame: up to 72 hours

  10. length of post-operative hospitalisation in days

    length of post-operative hospitalisation in days

    Time frame: up to 72 days

  11. Number of occurrences of nausea/vomiting, ileus, hypoxaemia, pruritus, confusion (CAM tool) after opioid administration

    Number of occurrences of nausea/vomiting, ileus, hypoxaemia, pruritus, confusion (CAM tool) after opioid administration

    Time frame: up to 72 hours

  12. Score of satisfaction with pain management

    Score of satisfaction with pain management, assessed on a numerical scale from 0-10 (0 total dissatisfaction, 10 total satisfaction) at discharge from hospital

    Time frame: up to 72 hours

  13. Number of patients taking opioids daily

    Number of patients taking opioids daily at 1 months after hospital discharge. Assessment of risk of misuse: POMI-5F scale.

    Time frame: at 1 month

  14. Number of patients taking opioids daily

    Number of patients taking opioids daily at 3 months after hospital discharge. Assessment of risk of misuse: POMI-5F scale.

    Time frame: at 3 months

  15. Number of patients with chronic postoperative pain

    Number of patients with chronic postoperative pain 3 months after surgery

    Time frame: at 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Apr 2028, 28 months after the start.

Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 28 months is above that.

Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2026
First posted
Nov 3, 2026
StartActual
Dec 22, 2025
Primary completionEst.
Apr 2028
CompletionEst.
Jul 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07914335
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Dec 22, 2025
Primary completion
Apr 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Paul Tarpin, MD
Contact
tarpin.paul@chu-amiens.fr
33+322089108

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Morphine

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