Use Of Epidurals Intraoperatively For Patients Undergoing Pancreas Resection

Study Overview

Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

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.

N/A

Pancreatic Cancer

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

18-056

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-02-08	Results First Submitted 2025-06-17	Last Update Submitted that met QC Criteria 2025-07-11
First Submitted that Met QC Criteria 2018-02-13	Results First Submitted that Met QC Criteria 2025-07-11	Last Update Posted (ACTUAL) 2025-07-30
First Posted (ACTUAL) 2018-02-15	Results First Posted 2025-07-30	Last Verified 2024-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Epidural-General Anesthesia	DRUG: Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml 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. PROCEDURE: Open Pancreaticoduodenectomy Whipple' Procedure
ACTIVE_COMPARATOR: General Anesthesia	DRUG: Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml 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. DRUG: Propofol+ Rocuronium+ Fentanyl + Inhalational Patient will have the standard intraoperative management during surgery and have the epidural started just before being taken to the recovery room. PROCEDURE: Open Pancreaticoduodenectomy Whipple' Procedure

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Epidural-General Anesthesia

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

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.

PROCEDURE: Open Pancreaticoduodenectomy

Whipple' Procedure

ACTIVE_COMPARATOR: General Anesthesia

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

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.

DRUG: Propofol+ Rocuronium+ Fentanyl + Inhalational

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

PROCEDURE: Open Pancreaticoduodenectomy

Whipple' Procedure

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Florence Grant, MD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record