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Trial Outcomes & Findings for Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection (NCT NCT03434678)

NCT ID: NCT03434678

Last Updated: 2025-07-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

133 participants

Primary outcome timeframe

90 days post operatively

Results posted on

2025-07-30

Participant Flow

Participant milestones

Participant milestones
Measure
Epidural-General Anesthesia
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. Open Pancreaticoduodenectomy: Whipple' Procedure
General Anesthesia
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. Open Pancreaticoduodenectomy: Whipple' Procedure
Overall Study
STARTED
65
68
Overall Study
COMPLETED
50
54
Overall Study
NOT COMPLETED
15
14

Reasons for withdrawal

Reasons for withdrawal
Measure
Epidural-General Anesthesia
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. Open Pancreaticoduodenectomy: Whipple' Procedure
General Anesthesia
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. Open Pancreaticoduodenectomy: Whipple' Procedure
Overall Study
Withdrawal by Subject
13
13
Overall Study
Found to be ineligible post randomization
2
1

Baseline Characteristics

Use of Epidurals Intraoperatively for Patients Undergoing Pancreas Resection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Epidural-General Anesthesia
n=50 Participants
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. Open Pancreaticoduodenectomy: Whipple' Procedure
General Anesthesia
n=54 Participants
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. Open Pancreaticoduodenectomy: Whipple' Procedure
Total
n=104 Participants
Total of all reporting groups
Age, Continuous
66 years
n=5 Participants
68 years
n=7 Participants
67 years
n=5 Participants
Sex: Female, Male
Female
15 Participants
n=5 Participants
25 Participants
n=7 Participants
40 Participants
n=5 Participants
Sex: Female, Male
Male
35 Participants
n=5 Participants
29 Participants
n=7 Participants
64 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=5 Participants
2 Participants
n=7 Participants
7 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
42 Participants
n=5 Participants
47 Participants
n=7 Participants
89 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
5 Participants
n=7 Participants
8 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
4 Participants
n=5 Participants
0 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
Race (NIH/OMB)
White
41 Participants
n=5 Participants
45 Participants
n=7 Participants
86 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
50 Participants
n=5 Participants
54 Participants
n=7 Participants
104 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Epidural-General Anesthesia
n=50 Participants
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. Open Pancreaticoduodenectomy: Whipple' Procedure
General Anesthesia
n=54 Participants
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. Open Pancreaticoduodenectomy: Whipple' Procedure
Number of Incidences of Grade 3 or Greater Complications
0 Number of complications
0 Number of complications

Adverse Events

Epidural-General Anesthesia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 23 deaths

General Anesthesia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 24 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Florence Grant, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-8829

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place