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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peridural | Active Comparator | Patients will receive standard multimodal analgesic medications plus epidural analgesia during the postoperative period. |
|
| Nefopam | Experimental | Patients will receive standard multimodal analgesic medications plus continuous nefopam infusion from the intraoperative through the postoperative period. |
|
| Lidocaine | Active Comparator | Patients will receive standard multimodal analgesic medications plus continuous lidocaine infusion from the intraoperative through the postoperative period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nefopam 120mg/day infusion | Drug | Nefopam administration will start in the intraoperative period and continue for 48 hours in the postoperative period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From enrollment to 48 hours after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery (QoR-15) | Quality of Recovery (QoR-15) scores, assessed preoperatively and at 24 and 48 hours after surgery. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrei O Mitre | Contact | +40724275556 | andrei.otto.mitre@elearn.umfcluj.ro |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. O. Fodor Regional Institute of Gastroenterology and Hepatology | Recruiting | Cluj-Napoca | Cluj | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14690106 | Result | 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. | |
| 28192892 | Result | Cuvillon 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. |
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| Lidocaine Infusion | Drug | Lidocaine infusion will begin in the intraoperative period and continue in the postoperative period for 48 hours |
|
| Peridural | Drug | This group will receive the stardad practice in our hospital, peridural analgesia alongside a multimodal analgesic approach involving paracetamol 4g/day |
|
| Multimodal IV analgesia | Drug | Standard postoperative multimodal pain management regimen |
|
|
| From enrollment to 48 hours postoperative |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009340 | Nefopam |
| D000082 | Acetaminophen |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D010079 | Oxazocines |
| D001392 | Azocines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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