Clinical trial · Interventional
Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection
Randomized Controlled Trial of Epidural-General Anesthesia Versus General Anesthesia for Open Pancreaticoduodenectomy: Influence on Complications and Overall Two Year Survival
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Open Pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
| Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml | Drug | — | UNRESOLVED |
| Propofol+ Rocuronium+ Fentanyl + Inhalational | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Epidural-General Anesthesia
- interventionNames
- Drug: Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml
- Procedure: Open Pancreaticoduodenectomy
- type
- ACTIVE_COMPARATOR
- label
- General Anesthesia
- interventionNames
- Drug: Propofol+ Rocuronium+ Fentanyl + Inhalational
- Procedure: Open Pancreaticoduodenectomy
Primary outcomes (1)
- measure
- Number of Incidences of Grade 3 or Greater Complications
- timeFrame
- 90 days post operatively
- description
- Complications will be graded in severity according to the MSKCC Graded Post Operative Complications Criteria based on the modified Dindo, Clavien classification of surgical complications, a grading system commonly used for this procedure.3,4 This classification grades complications from 1-5, with Grade 1 complications requiring bedside intervention. Grade 2 requires moderate interventions, such as intravenous medications. Grade 3 requires either a surgical, endoscopic or interventional radiology procedure for treatment. Grade 4 results in chronic deficit or disability. Grade 5 complications result in death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available