PancreatoduodenectomyPhase 4NCT07423650
Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy
A Phase 4 study testing Nefopam 120mg/day infusion, Lidocaine Infusion and Peridural in people with Pancreatoduodenectomy and Pain Management, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The goal of this clinical trial is to determine whether continuous nefopam administration, as part of a multimodal analgesia strategy, reduces opioid consumption and improves patient satisfaction after pancreatoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatoduodenectomy, Pain Management, Opioid Analgesia
- What is being tested?
- Nefopam 120mg/day infusion, Lidocaine Infusion and Peridural
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteRomania
- Study dates
- Mar 2026to Oct 2026
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective pancreatoduodenectomy surgery
- Agreed to participate in the study
Who cannot join
- Refusal to participate
- Emergency surgery
- Patients with neurological disorders or other muscular or psychiatric disorders that impede communication
- Known allergic reactions to the used medication
- Known hyperalgesia
- Chronic opioid consumption
- Patients that require reintervention in the first 48h postoperatively
- Patients with pancreaticogastrostomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Prof. O. Fodor Regional Institute of Gastroenterology and Hepatology
Cluj-Napoca, Cluj
Andrei O Mitre, +40724275556, andrei.mitre97@gmail.com
About this study
Official title: Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy: A Randomized Controlled Double-Blind Trial
The goal of this clinical trial is to determine whether continuous nefopam administration, as part of a multimodal analgesia strategy, reduces opioid consumption and improves patient satisfaction after pancreatoduodenectomy.
The main questions are:
Read more
Does nefopam administration reduce opioid consumption after pancreatoduodenectomy?
Does nefopam administration reduce postoperative pain levels after pancreatoduodenectomy?
Researchers will compare two other analgesic strategies, namely continuous lidocaine infusion and epidural analgesia, to assess whether they lead to better outcomes.
Participants will complete the QoR-15 questionnaire and report their pain levels at predefined time points before and after surgery.
- Being tested
- Nefopam 120mg/day infusion, Lidocaine Infusion, Peridural, Multimodal IV analgesia
- Keywords
- Nefopam, Pancreatoduodenectomy, Opioids, Multimodal analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nefopam 120mg/day infusionDrug
Nefopam administration will start in the intraoperative period and continue for 48 hours in the postoperative period
Lidocaine InfusionDrug
Lidocaine infusion will begin in the intraoperative period and continue in the postoperative period for 48 hours
PeriduralDrug
This group will receive the stardad practice in our hospital, peridural analgesia alongside a multimodal analgesic approach involving paracetamol 4g/day
Multimodal IV analgesiaDrug
Also called Ketoprofene, Paracetamol, Morphine
Standard postoperative multimodal pain management regimen
| Study group | Role | What they receive |
|---|---|---|
| Peridural | Active comparator | Patients will receive standard multimodal analgesic medications plus epidural analgesia during the postoperative period. Receives: Drug: Peridural; Drug: Multimodal IV analgesia |
| Nefopam | Experimental | Patients will receive standard multimodal analgesic medications plus continuous nefopam infusion from the intraoperative through the postoperative period. Receives: Drug: Nefopam 120mg/day infusion; Drug: Multimodal IV analgesia |
| Lidocaine | Active comparator | Patients will receive standard multimodal analgesic medications plus continuous lidocaine infusion from the intraoperative through the postoperative period. Receives: Drug: Lidocaine Infusion; Drug: Multimodal IV analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Perioperative opioid consumption, expressed in morphine milligram equivalents, during the intraoperative period and within the first 6, 18, 24, and 48 hours postoperatively.
Measured: From enrollment to 48 hours after the surgery
Pain levels after surgery
Numeric Rating Scale (NRS) pain scores at rest and during straining (coughing), assessed at 30 minutes, 6 hours, 18 hours, 24 hours, and 48 hours postoperatively.
Measured: From enrollment to 48 hours after the surgery
Secondary outcomes (2)
Quality of Recovery (QoR-15)
Quality of Recovery (QoR-15) scores, assessed preoperatively and at 24 and 48 hours after surgery.
Measured: From enrollment to 48 hours after the surgery
Adverse events
Incidence of adverse events: pruritus, tachycardia, bradycardia, arrhythmia, lidocaine toxicity signs (metallic taste in the mouth, oral numbness, tinnitus, blurred vision), nausea, vomiting, rescue antiemetic etc.
Measured: From enrollment to 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PancreatoduodenectomyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrei Mitre, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423650
- Sponsor's protocol ID
- 11348/25.09.2025
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tramoni G, Viale JP, Cazals C, Bhageerutty K. Morphine-sparing effect of nefopam by continuous intravenous injection after abdominal surgery by laparotomy. Eur J Anaesthesiol. 2003 Dec;20(12):990-2. doi: 10.1017/s0265021503251590. No abstract available.
PubMed 14690106Cuvillon P, Zoric L, Demattei C, Alonso S, Casano F, L'hermite J, Ripart J, Lefrant JY, Muller L. Opioid-sparing effect of nefopam in combination with paracetamol after major abdominal surgery: a randomized double-blind study. Minerva Anestesiol. 2017 Sep;83(9):914-920. doi: 10.23736/S0375-9393.17.11508-7. Epub 2017 Feb 13.
PubMed 28192892
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy: A Randomized Controlled Double-Blind Trial
- ClinicalTrials.gov ID
- NCT07423650
- Acronym / sponsor ID
- 11348/25.09.2025
- Keywords
- Nefopam, Pancreatoduodenectomy, Opioids, Multimodal analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 Feb 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.
The goal of this clinical trial is to determine whether continuous nefopam administration, as part of a multimodal analgesia strategy, reduces opioid consumption and improves patient satisfaction after pancreatoduodenectomy.
The main questions are:
Does nefopam administration reduce opioid consumption after pancreatoduodenectomy?
Does nefopam administration reduce postoperative pain levels after pancreatoduodenectomy?
Researchers will compare two other analgesic strategies, namely continuous lidocaine infusion and epidural analgesia, to assess whether they lead to better outcomes.
Participants will complete the QoR-15 questionnaire and report their pain levels at predefined time points before and after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peridural | Active comparator | Drug: Peridural, Drug: Multimodal IV analgesiaPatients will receive standard multimodal analgesic medications plus epidural analgesia during the postoperative period. |
| Nefopam | Experimental | Drug: Nefopam 120mg/day infusion, Drug: Multimodal IV analgesiaPatients will receive standard multimodal analgesic medications plus continuous nefopam infusion from the intraoperative through the postoperative period. |
| Lidocaine | Active comparator | Drug: Lidocaine Infusion, Drug: Multimodal IV analgesiaPatients will receive standard multimodal analgesic medications plus continuous lidocaine infusion from the intraoperative through the postoperative period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective pancreatoduodenectomy surgery
- Agreed to participate in the study
Key exclusion criteria (8 listed)
- Refusal to participate
- Emergency surgery
- Patients with neurological disorders or other muscular or psychiatric disorders that impede communication
- Known allergic reactions to the used medication
- Known hyperalgesia
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 |
|---|---|---|
| Nefopam 120mg/day infusionNefopam administration will start in the intraoperative period and continue for 48 hours in the postoperative period | Drug | Nefopam |
| Lidocaine InfusionLidocaine infusion will begin in the intraoperative period and continue in the postoperative period for 48 hours | Drug | Lidocaine |
| PeriduralThis group will receive the stardad practice in our hospital, peridural analgesia alongside a multimodal analgesic approach involving paracetamol 4g/day | Drug | Peridural |
| Multimodal IV analgesiaAlso: Ketoprofene, Paracetamol, MorphineStandard postoperative multimodal pain management regimen | Drug | Lidocaine, Nefopam, Peridural |
Primary outcome
Opioid consumption
Time frame: From enrollment to 48 hours after the surgery
Perioperative opioid consumption, expressed in morphine milligram equivalents, during the intraoperative period and within the first 6, 18, 24, and 48 hours postoperatively.
Pain levels after surgery
Time frame: From enrollment to 48 hours after the surgery
Numeric Rating Scale (NRS) pain scores at rest and during straining (coughing), assessed at 30 minutes, 6 hours, 18 hours, 24 hours, and 48 hours postoperatively.
2 secondary outcomes
Quality of Recovery (QoR-15)
Time frame: From enrollment to 48 hours after the surgery
Adverse events
Time frame: From enrollment to 48 hours postoperative
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 24 Mar 2026.
- Results publication: PubMed 14690106Tramoni G, Viale JP, Cazals C, Bhageerutty K. Morphine-sparing effect of nefopam by continuous intravenous injection after abdominal surgery by laparotomy. Eur J Anaesthesiol. 2003 Dec;20(12):990-2. doi: 10.1017/s0265021503251590. No abstract available.
- Results publication: PubMed 28192892Cuvillon P, Zoric L, Demattei C, Alonso S, Casano F, L'hermite J, Ripart J, Lefrant JY, Muller L. Opioid-sparing effect of nefopam in combination with paracetamol after major abdominal surgery: a randomized double-blind study. Minerva Anestesiol. 2017 Sep;83(9):914-920. doi: 10.23736/S0375-9393.17.11508-7. Epub 2017 Feb 13.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing Nefopam 120mg/day infusion, Lidocaine Infusion and Peridural in people with Pancreatoduodenectomy and Pain Management, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 2 inclusion and 8 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 24 Mar 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 Romania. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Andrei O Mitre (+40724275556, andrei.otto.mitre@elearn.umfcluj.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: From enrollment to 48 hours after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07423650, which also lists 2 linked publications.
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 24 Mar 2026.