NCT02681796CompletedPhase 1
Epidural Analgesia Use in Pancreatic Resections
Washington University School of Medicine1 site in 1 country23 target enrollmentStarted: June 7, 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Total consumption of morphine or morphine-equivalent in patients undergoing pancreatic resections in the control group compared with the study group
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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
Intervention: Bupivacaine (Drug)
Outcomes
Primary Outcomes
Total consumption of morphine or morphine-equivalent in patients undergoing pancreatic resections in the control group compared with the study group
Time Frame: First 72 hours after surgery
-Will be assessed every 24 hours
Secondary Outcomes
- 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 relative ratios of blood level inflammatory markers(Up to 6 weeks post-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)
- Benefit of epidural analgesia as measured by disease-free survival(Up to 2 years post surgery)
- 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 time to tumor recurrence(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 length of hospital stay(Up to 2 weeks 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 incidence of deep venous thromboembolism/pulmonary embolism(Up to 72 hours post surgery)
Investigators
Study Sites (1)
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