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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural-General Anesthesia | Experimental |
| |
| General Anesthesia | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days post operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence Grant, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent only) | Basking Ridge | New Jersey | 07920 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2020 |
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Prospective randomized controlled single institution trial.
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(surgical staff) blinded
| Propofol+ Rocuronium+ Fentanyl + Inhalational | Drug | Patient will have the standard intraoperative management during surgery and have the epidural started just before being taken to the recovery room. |
|
| Open Pancreaticoduodenectomy | Procedure | Whipple' Procedure |
|
| Memorial Sloan Kettering Commack (Consent only) |
| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| FG001 |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Number of complications | 90 days post operatively |
|
|
|
90 days post operatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 23 | 50 | 0 | 50 | 0 | 50 |
| EG001 | 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 | 24 | 54 | 0 | 54 | 0 | 54 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Florence Grant, MD | Memorial Sloan Kettering Cancer Center | 212-639-8829 | moses-gf@mskcc.org |
| Jul 11, 2025 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|