Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03434678
• Collaborator: (none)
• Enrollment: 133
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 71
• Patients Per Site: 44.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml; Drug: Propofol+ Rocuronium+ Fentanyl + Inhalational; Procedure: Open Pancreaticoduodenectomy	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 133 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective randomized controlled single institution trial.Prospective randomized controlled single institution trial.
• Masking: Single (Investigator)
• Masking Description: (surgical staff) blinded
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Epidural-General Anesthesia Versus General Anesthesia for Open Pancreaticoduodenectomy: Influence on Complications and Overall Two Year Survival
• Actual Study Start Date: Jan 30, 2018
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Epidural-General Anesthesia	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.; Procedure: Open Pancreaticoduodenectomy; Whipple' Procedure
Active Comparator: General Anesthesia	Drug: 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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral 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

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Florence Grant, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT03434678
• Other Study ID Numbers: 18-056
• First Posted: Feb 15, 2018
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Memorial Sloan Kettering Cancer Center: General Anesthesia; Epidural; Pancreaticoduodenectomy; 18-056
• Additional relevant MeSH terms: Fentanyl; Bupivacaine; Propofol; Rocuronium

Study Results

No Results Posted as of Aug 9, 2022