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Completed

NCT Number: NCT02681796

Epidural Analgesia Use in Pancreatic Resections

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.

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Key information

Conditions

Cancer of Pancreas Cancer of the Pancreas Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreas Cancer Pancreas Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

Primary outcomes

  1. 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

  1. Effect of epidural analgesia during the initial post-operative period as measured by total intraoperative fluid volume

    Time frame: During surgery

  2. Benefit of epidural analgesia as measured by the reduction of persistent post-surgical pain (PPSP) after the operation

    Time frame: Up to 6 weeks post-surgery

    -Quantitative sensory testing will be performed on the abdomen in close proximity to the surgical incision

  3. Benefit of epidural analgesia as measured by time to tumor recurrence

    Time frame: Up to 2 years post surgery

  4. Benefit of epidural analgesia as measured by disease-free survival

    Time frame: Up to 2 years post surgery

  5. Benefit of epidural analgesia as measured by overall survival

    Time frame: Up to 2 years post surgery

  6. Rate of delirium in the control group compared with the study group

    Time frame: 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

  7. Effect of epidural analgesia during the initial post-operative period as measured by total post-operative fluid volume

    Time frame: Up to 72 hours post surgery

  8. Effect of epidural analgesia during the initial post-operative period as measured by volume of fluid boluses

    Time frame: Up to 72 hours post surgery

  9. Effect of epidural analgesia during the initial post-operative period as measured by amount of antiemetic doses

    Time frame: Up to 72 hours post surgery

  10. Effect of epidural analgesia during the initial post-operative period as measured by return of bowel function by time to first flatus

    Time frame: Up to 72 hours post surgery

  11. Effect of epidural analgesia during the initial post-operative period as measured by first bowel movement

    Time frame: Up to 72 hours post surgery

  12. Effect of epidural analgesia during the initial post-operative period as measured by length of hospital stay

    Time frame: Up to 2 weeks post surgery

  13. Effect of epidural analgesia during the initial post-operative period as measured by incidence of deep venous thromboembolism/pulmonary embolism

    Time frame: Up to 72 hours post surgery

  14. Effect of epidural analgesia during the initial post-operative period as measured by relative ratios of blood level inflammatory markers

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: E-PRO I

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 12, 2016
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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