Randomized Controlled Trial of Epidural-General Anesthesia Versus General Anesthesia for Open Pancreaticoduodenectomy: Influence on Complications and Overall Two Year Survival
Overview
- Phase
- Phase 3
- Intervention
- Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml
- Conditions
- Pancreatic Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 133
- Locations
- 3
- Primary Endpoint
- Number of Incidences of Grade 3 or Greater Complications
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
Epidural-General Anesthesia
Intervention: Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml
Epidural-General Anesthesia
Intervention: Open Pancreaticoduodenectomy
General Anesthesia
Intervention: Propofol+ Rocuronium+ Fentanyl + Inhalational
General Anesthesia
Intervention: Open Pancreaticoduodenectomy
Outcomes
Primary Outcomes
Number of Incidences 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.