Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2024-07-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled single institution trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

(surgical staff) blinded

Study Groups

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Epidural-General Anesthesia

Group Type EXPERIMENTAL

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

Intervention Type 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.

Open Pancreaticoduodenectomy

Intervention Type PROCEDURE

Whipple' Procedure

General Anesthesia

Group Type ACTIVE_COMPARATOR

Propofol+ Rocuronium+ Fentanyl + Inhalational

Intervention Type DRUG

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

Open Pancreaticoduodenectomy

Intervention Type PROCEDURE

Whipple' Procedure

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Open Pancreaticoduodenectomy

Whipple' Procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No