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Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434678
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : January 30, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434678


Contacts
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Contact: Florence Grant, MD 212-639-8829 moses-gf@mskcc.org
Contact: William Jarnagin, MD 212-639-7601

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent only) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Florence Grant, MD    212-639-8829      
United States, New York
Memorial Sloan Kettering Commack (Consent only) Recruiting
Commack, New York, United States, 11725
Contact: Florence Grant, MD    212-639-8829      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Florence Grant, MD    212-639-8829      
Contact: William JJarnagin, MD    212-639-7601      
Principal Investigator: Florence Grant, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Florence Grant, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03434678    
Other Study ID Numbers: 18-056
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020

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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:
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Fentanyl
Bupivacaine
Propofol
Rocuronium
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents