Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

NCT03434678 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 18-056
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pancreatic Cancer

Keywords

General Anesthesia; Epidural; Pancreaticoduodenectomy; 18-056

Outcome Measures

Primary Outcomes (1)

• Number of Incidences of Grade 3 or Greater Complications

  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.

  90 days post operatively

Study Arms (2)

Epidural-General Anesthesia

EXPERIMENTAL

Drug: Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml; Procedure: Open Pancreaticoduodenectomy

General Anesthesia

ACTIVE COMPARATOR

Drug: Propofol+ Rocuronium+ Fentanyl + Inhalational; Procedure: Open Pancreaticoduodenectomy

Interventions

Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml DRUG

Patient will have their epidural started at the beginning of the surgery and receive fewer opioid drugs. The epidural is continued into the recovery room.

Epidural-General Anesthesia

Propofol+ Rocuronium+ Fentanyl + Inhalational DRUG

Patient will have the standard intraoperative management during surgery and have the epidural started just before being taken to the recovery room.

General Anesthesia

Open Pancreaticoduodenectomy PROCEDURE

Whipple' Procedure

Epidural-General Anesthesia; General Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients ≥ 18 years of age who can provide informed consent
• Scheduled for pancreaticoduodenectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (3)

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Florence Grant, MD
• Organization: Memorial Sloan Kettering Cancer Center

moses-gf@mskcc.org

212-639-8829

Study Officials

• Florence Grant, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: (surgical staff) blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized controlled single institution trial.

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 15, 2018
• Study Start: January 30, 2018
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2024-07

Locations

US (3)