Phase 3
N=133
Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03434678 ↗Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Number of Incidences of Grade 3 or Greater Complications — 0; 0 Number of complications
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml (Drug); Propofol+ Rocuronium+ Fentanyl + Inhalational (Drug); Open Pancreaticoduodenectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Incidences of Grade 3 or Greater Complications |
0; 0 | — |
Summary
The purpose of this study is to see if there is a difference in complications in patients who have an epidural started earlier (during their surgery) and used as part of the anesthetic in addition to using it for post operative pain compared with patients who receive an epidural later in the surgery to be used only for post operative pain.
Eligibility Criteria
Inclusion Criteria
- Adult patients ≥ 18 years of age who can provide informed consent
- Scheduled for pancreaticoduodenectomy
Exclusion Criteria
- Pregnancy
- History of documented anaphylaxis or contraindication to any of the study medications
- Significant cognitive impairment or documented psychologic impairment
- Contraindication to epidural per Pain Service guidelines
- Use of a sustained release opioid medication such as long-acting morphine, fentanyl patches, methadone, and buprenorphine within the last 3 months
- Post randomization exclusion will occur if the patient is found to have unresectable disease at laparotomy and therefore will not have the potential for the same postoperative complications.
Data sourced from ClinicalTrials.gov (NCT03434678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.