Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03434678
• Other study ID #: 18-056
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 30, 2018
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center