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The rationale for this study is to investigate the benefits of epidural analgesia in pancreatic resections in a prospective, single blind, randomized control trial. This study will evaluate both short and long-term outcomes related to epidural analgesia, providing a longitudinal and comprehensive perspective to the advantages and disadvantages of this technique. The investigators hypothesize that the use of epidural analgesia reduces a patient's consumption of morphine or morphine-equivalent in the post-operative period following pancreatic resections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study: Bupivacaine Epidural + standard of care pain regimen | Experimental | -The study group will receive a T6 to T8 level epidural catheter in addition to the standardized pain regimen. Epidurals used in this study will contain a 0.125% bupivacaine-only infusion |
|
| Control: Standard of care pain regimen | No Intervention | -The control group will receive a standardized pain regimen including an opioid patient controlled analgesia (PCA), IV acetaminophen, and IV ketorolac per surgeon's preference |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total consumption of morphine or morphine-equivalent in patients undergoing pancreatic resections in the control group compared with the study group | -Will be assessed every 24 hours | First 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of epidural analgesia during the initial post-operative period as measured by total intraoperative fluid volume | During surgery | |
| Benefit of epidural analgesia as measured by the reduction of persistent post-surgical pain (PPSP) after the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Bottros, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29374667 | Derived | Pak LM, Haroutounian S, Hawkins WG, Worley L, Kurtz M, Frey K, Karanikolas M, Swarm RA, Bottros MM. Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial. BMJ Open. 2018 Jan 26;8(1):e018787. doi: 10.1136/bmjopen-2017-018787. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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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 |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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-Quantitative sensory testing will be performed on the abdomen in close proximity to the surgical incision
| Up to 6 weeks post-surgery |
| Benefit of epidural analgesia as measured by time to tumor recurrence | Up to 2 years post surgery |
| Benefit of epidural analgesia as measured by disease-free survival | Up to 2 years post surgery |
| Benefit of epidural analgesia as measured by overall survival | Up to 2 years post surgery |
| Rate of delirium in the control group compared with the study group |
| First 72 hours after surgery |
| Effect of epidural analgesia during the initial post-operative period as measured by total post-operative fluid volume | Up to 72 hours post surgery |
| Effect of epidural analgesia during the initial post-operative period as measured by volume of fluid boluses | Up to 72 hours post surgery |
| Effect of epidural analgesia during the initial post-operative period as measured by amount of antiemetic doses | Up to 72 hours post surgery |
| Effect of epidural analgesia during the initial post-operative period as measured by return of bowel function by time to first flatus | Up to 72 hours post surgery |
| Effect of epidural analgesia during the initial post-operative period as measured by first bowel movement | Up to 72 hours post surgery |
| Effect of epidural analgesia during the initial post-operative period as measured by length of hospital stay | Up to 2 weeks post surgery |
| Effect of epidural analgesia during the initial post-operative period as measured by incidence of deep venous thromboembolism/pulmonary embolism | Up to 72 hours post surgery |
| Effect of epidural analgesia during the initial post-operative period as measured by relative ratios of blood level inflammatory markers | -Specifically interleukin-1-beta (IL-1B), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-a), and interleukin 10 (IL-10) biomarkers | Up to 6 weeks post-surgery |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000588 |
| Amines |