E-PRO I: Epidural Analgesia Use in Pancreatic Resections
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Study: Bupivacaine Epidural + standard of care pain regimen -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 |
Drug: Bupivacaine
|
No Intervention: Control: Standard of care pain regimen -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 |
Outcome Measures
Primary Outcome Measures
- Total consumption of morphine or morphine-equivalent in patients undergoing pancreatic resections in the control group compared with the study group [First 72 hours after surgery]
-Will be assessed every 24 hours
Secondary Outcome Measures
- 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 [Up to 6 weeks post-surgery]
-Quantitative sensory testing will be performed on the abdomen in close proximity to the surgical incision
- 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]
Assessed for delirium using the 3D-CAM instrument Postoperative delirium assessments will be performed when patients can be around sufficiently in order to be assessed for delirium using the Richmond-Agitation-Sedation Scale. Will be assessed for delirium once daily in the afternoon/evening
- 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 [Up to 6 weeks post-surgery]
-Specifically interleukin-1-beta (IL-1B), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-a), and interleukin 10 (IL-10) biomarkers
Eligibility Criteria
Criteria
Inclusion Criteria:
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Undergoing pancreatic resection.
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Age ≥18 years old.
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Able to understand and sign an Institutional Review Board (IRB)-approved informed consent form.
Exclusion Criteria:
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Indication for operative intervention being chronic pancreatitis.
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Currently on warfarin with an INR≥1.4 or clopidogrel that cannot be discontinued 7 days prior to surgery;
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Most recent INR prior to surgery >1.4
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Most recent platelet count prior to surgery <70,000/mcl
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Chronic opioid use as defined by use of more than 20mg oxycodone, or equivalent, daily.
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History of pre-existing neuropathic pain conditions.
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Not giving consent for study participation.
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Known medical history of significant psychiatric or cognitive impairment
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History of HIV, Hepatitis B, and/or Hepatitis C
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
- Principal Investigator: Michael Bottros, M.D., Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 201506125