Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

Memorial Sloan Kettering Cancer Center133 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

133

Conditions

Pancreatic Cancer

Interventions

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

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.

Propofol+ Rocuronium+ Fentanyl + InhalationalDRUG

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

Open PancreaticoduodenectomyPROCEDURE

Whipple' Procedure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 90 days post operatively

Data from ClinicalTrials.gov

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