E-PRO I: Epidural Analgesia Use in Pancreatic Resections

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02681796
Collaborator
(none)
23
1
2
44
0.5

Study Details

Study Description

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
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Epidural Analgesia Use in Pancreatic Resections
Actual Study Start Date :
Jun 7, 2016
Actual Primary Completion Date :
Feb 7, 2020
Actual Study Completion Date :
Feb 7, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study: Bupivacaine Epidural + standard of care pain regimen

-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

No Intervention: Control: Standard of care pain regimen

-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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

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

  2. 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

  3. Benefit of epidural analgesia as measured by time to tumor recurrence [Up to 2 years post surgery]

  4. Benefit of epidural analgesia as measured by disease-free survival [Up to 2 years post surgery]

  5. Benefit of epidural analgesia as measured by overall survival [Up to 2 years post surgery]

  6. 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

  7. Effect of epidural analgesia during the initial post-operative period as measured by total post-operative fluid volume [Up to 72 hours post surgery]

  8. Effect of epidural analgesia during the initial post-operative period as measured by volume of fluid boluses [Up to 72 hours post surgery]

  9. Effect of epidural analgesia during the initial post-operative period as measured by amount of antiemetic doses [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 [Up to 72 hours post surgery]

  11. Effect of epidural analgesia during the initial post-operative period as measured by first bowel movement [Up to 72 hours post surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

  • Principal Investigator: Michael Bottros, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02681796
Other Study ID Numbers:
  • 201506125
First Posted:
Feb 12, 2016
Last Update Posted:
Mar 12, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 12, 2020