Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

Description

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.

Study Start Date

January, 30 2018

Estimated Completion Date

January 2021

Interventions

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

Study ID

Memorial Sloan Kettering Cancer Center -- 18-056

Status

Recruiting

Trial ID

NCT03434678

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

336

Sponsor

Memorial Sloan Kettering Cancer Center

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 placement including bleeding diatheses, neurologic dysfunction, prior extensive spinal surgery, pre-operative use of anti-coagulant with planned use of therapeutic anti-coagulation post-operatively, documented preoperative coagulopathy (INR > 1.3, aPTT greater than 42), platelet count < 100,000/mcg/L or evidence of infection at placement site
  • 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.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Memorial Sloan Kettering Cancer Center - New York, New York 50.7 miles Florence Grant MD 212-639-8829 None
Memoral Sloan Kettering Basking Ridge Consent only - Basking Ridge, New Jersey 78.1 miles Florence Grant MD 212-639-8829 None

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