Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 3

Conditions

Pancreatic Cancer

Treatments

Drug: Propofol+ Rocuronium+ Fentanyl + Inhalational

Procedure: Open Pancreaticoduodenectomy

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03434678

18-056

Details and patient eligibility

About

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.

Enrollment

133 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.