Cancer of Pancreas, Cancer of the Pancreas, Pancreas Cancer, Pancreas Neoplasms, Pancreatic Cancer
Conditions
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.
Interventions
DRUGBupivacaine
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 total intraoperative fluid volume | During 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 |
| Effect of epidural analgesia during the initial post-operative period as measured by volume of fluid boluses | Up to 72 hours post surgery | — |
Countries
United States
Outcome results
None listed