Status:

COMPLETED

Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

Lead Sponsor:

Memorial Sloan Kettering Cancer Center

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

January 30 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 10 2024

Estimated Enrollment :

133 Patients enrolled

Trial Details

Trial ID

NCT03434678

Start Date

January 30 2018

End Date

July 10 2024

Last Update

July 30 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, United States, 07920

2

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, United States, 11725

3

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065