Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

Phase 3

Completed

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

• Registration Number: NCT03434678
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-30
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-15
• Status Verified: 2024-07
• Primary Completion: 2024-07-10
• Study Completion: 2024-07-10
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural-General Anesthesia	Open Pancreaticoduodenectomy	-
General Anesthesia	Open Pancreaticoduodenectomy	-
General Anesthesia	Propofol+ Rocuronium+ Fentanyl + Inhalational	-
Epidural-General Anesthesia	Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml	-

Primary Outcome Measures

Name	Time	Method
incidence of grade 3 or greater complications	90 days post operatively	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.

Trial Locations

Locations (3)

Memorial Sloan Kettering Basking Ridge (Consent only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Commack (Consent only); 🇺🇸 Commack, New York, United States