Pancreatic Cancer
Conditions
Keywords
General Anesthesia, Epidural, Pancreaticoduodenectomy, 18-056
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.
Interventions
DRUGPropofol+ 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.
DRUGPropofol+ 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.
PROCEDUREOpen Pancreaticoduodenectomy
Whipple' Procedure
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
(surgical staff) blinded
Intervention model description
Prospective randomized controlled single institution trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Incidences of Grade 3 or Greater Complications | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| 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 | 54 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Found to be ineligible post randomization | 2 | 1 |
| Overall Study | Withdrawal by Subject | 13 | 13 |
Baseline characteristics
| Characteristic | Epidural-General Anesthesia | Total | General Anesthesia |
|---|---|---|---|
| Age, Continuous | 66 years | 67 years | 68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 7 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 89 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 41 Participants | 86 Participants | 45 Participants |
| Region of Enrollment United States | 50 Participants | 104 Participants | 54 Participants |
| Sex: Female, Male Female | 15 Participants | 40 Participants | 25 Participants |
| Sex: Female, Male Male | 35 Participants | 64 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 23 / 50 | 24 / 54 |
| other Total, other adverse events | 0 / 50 | 0 / 54 |
| serious Total, serious adverse events | 0 / 50 | 0 / 54 |
Outcome results
Primary
Number of Incidences of Grade 3 or Greater Complications
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.
Time frame: 90 days post operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epidural-General Anesthesia | Number of Incidences of Grade 3 or Greater Complications | 0 Number of complications |
| General Anesthesia | Number of Incidences of Grade 3 or Greater Complications | 0 Number of complications |