Epidural Analgesia Use in Pancreatic Resections (E-PRO I)

The Washington University

Status and phase: Completed; Phase 1

Conditions: Cancer of Pancreas; Pancreas Cancer; Cancer of the Pancreas; Pancreatic Cancer; Pancreas Neoplasms

Treatments: Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02681796

201506125

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

Study: Bupivacaine Epidural + standard of care pain regimen

Experimental group

Description:

-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

Treatment:

Drug: Bupivacaine

Control: Standard of care pain regimen

No Intervention group

Description:

-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