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Intraoperative Epidural for Pancreas Surgery

Phase 3
Waitlist Available
Led By Florence Grant, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients scheduled for pancreaticoduodenectomy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post operatively
Awards & highlights

Study Summary

This trial is testing if starting an epidural earlier in surgery can help reduce complications.

Who is the study for?
This trial is for adults over 18 who can consent and are scheduled for pancreaticoduodenectomy. It's not for those with unresectable disease found during surgery, contraindications to epidurals, recent long-acting opioid use, pregnancy, or allergies to study medications.Check my eligibility
What is being tested?
The study tests if starting an epidural earlier during pancreas resection surgery (and using it both intraoperatively and postoperatively) leads to fewer complications compared to starting it later just for postoperative pain relief.See study design
What are the potential side effects?
Possible side effects include reactions at the epidural site, low blood pressure from bupivacaine, nausea or itching from fentanyl, and typical anesthesia risks like respiratory depression or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for surgery to remove part of my pancreas and small intestine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
incidence of grade 3 or greater complications

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Epidural-General AnesthesiaExperimental Treatment2 Interventions
Group II: General AnesthesiaActive Control2 Interventions

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,675 Total Patients Enrolled
Florence Grant, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
331 Total Patients Enrolled

Media Library

Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml Clinical Trial Eligibility Overview. Trial Name: NCT03434678 — Phase 3
Pancreatic Cancer Research Study Groups: Epidural-General Anesthesia, General Anesthesia
Pancreatic Cancer Clinical Trial 2023: Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml Highlights & Side Effects. Trial Name: NCT03434678 — Phase 3
Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml 2023 Treatment Timeline for Medical Study. Trial Name: NCT03434678 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this research project for study participants?

"This specific trial is not currently active, however, it was last updated on 8/8/2022. There are 648 other trials that are presently recruiting patients."

Answered by AI

What is the standard course of treatment for Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml?

"Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml is most often used for the treatment of permphigus; however, it can also be an effective medication for acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."

Answered by AI

Are there any other instances of research teams testing this mix of drugs on patients?

"At this moment, there are 244 ongoing clinical trials related to the use of Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml for medical purposes. Out of these 244 trials, 43 are currently in Phase 3. Many of the clinical trials for Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml are taking place in Germantown, Tennessee; however,"

Answered by AI

How many people are currently enrolled in this clinical trial?

"Unfortunately, this study is not recruiting new participants at the moment. It was originally posted on January 30th 2018 and updated for the last time on August 8th 2022. However, there are 404 other trials actively enrolling patients with malignant neoplasm of pancreas and 244 trials for Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml that you could explore."

Answered by AI

What is the FDA's opinion on using Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml?

"Given that this is a Phase 3 trial with supporting efficacy data and multiple rounds of safety data, our team has estimated the safety of Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml to be a 3 on our scale."

Answered by AI
~14 spots leftby Jan 2025