Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:43 AM
Study NCT ID:
NCT07423650
Status:
RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy
Sponsor:
Iuliu Hatieganu University of Medicine and Pharmacy
Organization:
Study Overview
Official Title:
Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy: A Randomized Controlled Double-Blind Trial
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: