Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

Study Overview
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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.

Official Title
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Randomized Controlled Trial of Epidural-General Anesthesia Versus General Anesthesia for Open Pancreaticoduodenectomy: Influence on Complications and Overall Two Year Survival

Conditions
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Pancreatic Cancer

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


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized controlled single institution trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural-General Anesthesia<br> | Drug: Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml<br>* 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.<br>Procedure: Open Pancreaticoduodenectomy<br>* Whipple' Procedure<br>|
| Active Comparator: General Anesthesia<br> | Drug: Propofol+ Rocuronium+ Fentanyl + Inhalational<br>* Patient will have the standard intraoperative management during surgery and have the epidural started just before being taken to the recovery room.<br>Procedure: Open Pancreaticoduodenectomy<br>* Whipple' Procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General Anesthesia, Epidural, Pancreaticoduodenectomy, 18-056