Epidural Analgesia Use in Pancreatic Resections

Study Overview
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Brief Summary
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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.

Official Title
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Epidural Analgesia Use in Pancreatic Resections

Conditions
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Cancer of Pancreas, Cancer of the Pancreas, Pancreas Cancer, Pancreas Neoplasms, Pancreatic Cancer

Intervention / Treatment
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* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing pancreatic resection. Age ≥18 years old. Able to understand and sign an Institutional Review Board (IRB)-approved informed consent form. Exclusion Criteria: Indication for operative intervention being chronic pancreatitis. Currently on warfarin with an INR≥1.4 or clopidogrel that cannot be discontinued 7 days prior to surgery; Most recent INR prior to surgery >1.4 Most recent platelet count prior to surgery <70,000/mcl Chronic opioid use as defined by use of more than 20mg oxycodone, or equivalent, daily. History of pre-existing neuropathic pain conditions. Not giving consent for study participation. Known medical history of significant psychiatric or cognitive impairment History of HIV, Hepatitis B, and/or Hepatitis C

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study: Bupivacaine Epidural + standard of care pain regimen<br>-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<br> <br> |
| No Intervention: Control: Standard of care pain regimen<br>-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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | -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 | 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 | 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 |