- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03434678
Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection
February 1, 2024 updated by: Memorial Sloan Kettering Cancer Center
Randomized Controlled Trial of Epidural-General Anesthesia Versus General Anesthesia for Open Pancreaticoduodenectomy: Influence on Complications and Overall Two Year Survival
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 Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
133
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge (Consent Only)
-
-
New York
-
Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack (Consent only)
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: General Anesthesia
|
Whipple' Procedure
Patient will have the standard intraoperative management during surgery and have the epidural started just before being taken to the recovery room.
|
Experimental: Epidural-General Anesthesia
|
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.
Whipple' Procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of grade 3 or greater complications
Time Frame: 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.
|
90 days post operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Florence Grant, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2018
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
February 8, 2018
First Submitted That Met QC Criteria
February 13, 2018
First Posted (Actual)
February 15, 2018
Study Record Updates
Last Update Posted (Actual)
February 2, 2024
Last Update Submitted That Met QC Criteria
February 1, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anesthetics, Local
- Neuromuscular Agents
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Fentanyl
- Propofol
- Bupivacaine
- Rocuronium
Other Study ID Numbers
- 18-056
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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