Multimodal AnalgesiaTRAMORNOTNCT07914335
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
A study testing Anesthesia induction, Anesthesia maintenance and Multimodal analgesia in people with Multimodal Analgesia and Tramadol, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multimodal Analgesia, Tramadol, Enhanced Recovery After Surgery
- What is being tested?
- Anesthesia induction, Anesthesia maintenance and Multimodal analgesia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Allergy or intolerance to any of the following medicines: paracetamol, nefopam, ketoprofen, tramadol, morphine, Sufentanil, lidocaine, propofol, ketamine, dexamethasone and droleptan.
- Contraindications 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens-Picardie
Amiens, 80054
Paul TARPIN, MD, 0322087980, Tarpin.Paul@chu-amiens.fr
Ottilie Fumery, MD
About this study
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.
- Conditions
- Multimodal Analgesia, Tramadol, Enhanced Recovery After Surgery, Opioid and Postoperative Pain
- Being tested
- Anesthesia induction, Anesthesia maintenance, Multimodal analgesia, Morphine, Tramadol
- Keywords
- Multimodal analgesia, Tramadol, Enhanced recovery after surgery, Opioid and Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia inductionOther
Anesthesia induction with Propofol, Ketamine, Sufentanil, Lidocaine, and Dexamethasone
Anesthesia maintenanceOther
Anesthesia maintenance with Sevoflurane, Sufentanil, and Lidocaine
Multimodal analgesiaOther
Multimodal analgesia with Paracetamol, Ketoprofen, and Nefopam.
MorphineDrug
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.
TramadolDrug
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
| Study group | Role | What they receive |
|---|---|---|
| morphine group | Experimental | Not described Receives: Other: Anesthesia induction; Other: Anesthesia maintenance; Other: Multimodal analgesia; Drug: Morphine |
| tramadol group | Active comparator | Not described Receives: Other: Anesthesia induction; Other: Anesthesia maintenance; Other: Multimodal analgesia; Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score validated in French QoR-15
Score validated in French QoR-15
Measured: at 24 hours
Secondary outcomes (15)
QoR-15 questionnaire score
QoR-15 questionnaire score
Measured: at 48 hours
QoR-15 questionnaire score
QoR-15 questionnaire score
Measured: at 72 hours
Mean scores (0-10) for postoperative pain
Mean scores (0-10) for postoperative pain in the PACU
Measured: at 24 hours
Mean scores (0-10) for postoperative pain
Mean scores (0-10) for postoperative pain in the PACU
Measured: at 48 hours
Mean scores (0-10) for postoperative pain
Mean scores (0-10) for postoperative pain in the PACU
Measured: at 72 hours
Consumption of opioids in morphine equivalent per os
Consumption of opioids in morphine equivalent per os
Measured: at 24 hours
Consumption of opioids in morphine equivalent per os
Consumption of opioids in morphine equivalent per os
Measured: at 72 hours
Analgesic efficacy
Analgesic efficacy after administration of an opioid assessed by NRS (0-10) 2 hours after administration of the opioid
Measured: 2 hours
Length of stay in the postoperative intensive care unit in minutes
Length of stay in the postoperative intensive care unit in minutes
Measured: up to 72 hours
length of post-operative hospitalisation in days
length of post-operative hospitalisation in days
Measured: up to 72 days
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
Measured: up to 72 hours
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
Measured: up to 72 hours
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.
Measured: at 1 month
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.
Measured: at 3 months
Number of patients with chronic postoperative pain
Number of patients with chronic postoperative pain 3 months after surgery
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start22 Dec 2025
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multimodal AnalgesiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914335
- Sponsor's protocol ID
- PI2025_843_0001
- Acronym
- TRAMORNOT
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07914335
- Acronym / sponsor ID
- TRAMORNOT / PI2025_843_0001
- Conditions
- Multimodal Analgesia, Tramadol, Enhanced Recovery After Surgery, Opioid and Postoperative Pain
- Keywords
- Multimodal analgesia, Tramadol, Enhanced recovery after surgery, Opioid and Postoperative pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morphine group | Experimental | Other: Anesthesia induction, Other: Anesthesia maintenance, Other: Multimodal analgesia, Drug: Morphine |
| tramadol group | Active comparator | Other: Anesthesia induction, Other: Anesthesia maintenance, Other: Multimodal analgesia, Drug: Tramadol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Allergy or intolerance to any of the following medicines: paracetamol, nefopam, ketoprofen, tramadol, morphine, Sufentanil, lidocaine, propofol, ketamine, dexamethasone and droleptan.
- Contraindications 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia inductionAnesthesia induction with Propofol, Ketamine, Sufentanil, Lidocaine, and Dexamethasone | Other | morphine group, tramadol group |
| Anesthesia maintenanceAnesthesia maintenance with Sevoflurane, Sufentanil, and Lidocaine | Other | morphine group, tramadol group |
| Multimodal analgesiaMultimodal analgesia with Paracetamol, Ketoprofen, and Nefopam. | Other | morphine group, tramadol group |
| MorphineMorphine 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. | Drug | morphine group |
| TramadolTramadol: 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 | Drug | tramadol group |
Primary outcome
Score validated in French QoR-15
Time frame: at 24 hours
Score validated in French QoR-15
15 secondary outcomes
QoR-15 questionnaire score
Time frame: at 48 hours
QoR-15 questionnaire score
Time frame: at 72 hours
Mean scores (0-10) for postoperative pain
Time frame: at 24 hours
Mean scores (0-10) for postoperative pain
Time frame: at 48 hours
Mean scores (0-10) for postoperative pain
Time frame: at 72 hours
Consumption of opioids in morphine equivalent per os
Time frame: at 24 hours
Consumption of opioids in morphine equivalent per os
Time frame: at 72 hours
Analgesic efficacy
Time frame: 2 hours
Length of stay in the postoperative intensive care unit in minutes
Time frame: up to 72 hours
length of post-operative hospitalisation in days
Time frame: up to 72 days
Number of occurrences of nausea/vomiting, ileus, hypoxaemia, pruritus, confusion (CAM tool) after opioid administration
Time frame: up to 72 hours
Score of satisfaction with pain management
Time frame: up to 72 hours
Number of patients taking opioids daily
Time frame: at 1 month
Number of patients taking opioids daily
Time frame: at 3 months
Number of patients with chronic postoperative pain
Time frame: at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthesia induction, Anesthesia maintenance and Multimodal analgesia in people with Multimodal Analgesia and Tramadol, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Tarpin, MD (33+322089108, tarpin.paul@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score validated in French QoR-15 (time frame: at 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.