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

Primary Purpose

Cancer of Pancreas, Cancer of the Pancreas, Pancreas Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer of Pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study: Bupivacaine Epidural + standard of care pain regimen

Control: Standard of care pain regimen

Arm 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

-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

Outcomes

Primary Outcome Measures

Total consumption of morphine or morphine-equivalent in patients undergoing pancreatic resections in the control group compared with the study group
-Will be assessed every 24 hours

Secondary Outcome Measures

Effect of epidural analgesia during the initial post-operative period as measured by total intraoperative fluid volume
Benefit of epidural analgesia as measured by the reduction of persistent post-surgical pain (PPSP) after the operation
-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
Benefit of epidural analgesia as measured by disease-free survival
Benefit of epidural analgesia as measured by overall survival
Rate of delirium in the control group compared with the study group
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
Effect of epidural analgesia during the initial post-operative period as measured by volume of fluid boluses
Effect of epidural analgesia during the initial post-operative period as measured by amount of antiemetic doses
Effect of epidural analgesia during the initial post-operative period as measured by return of bowel function by time to first flatus
Effect of epidural analgesia during the initial post-operative period as measured by first bowel movement
Effect of epidural analgesia during the initial post-operative period as measured by length of hospital stay
Effect of epidural analgesia during the initial post-operative period as measured by incidence of deep venous thromboembolism/pulmonary embolism
Effect of epidural analgesia during the initial post-operative period as measured by relative ratios of blood level inflammatory markers
-Specifically interleukin-1-beta (IL-1B), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-a), and interleukin 10 (IL-10) biomarkers

Full Information

First Posted
February 10, 2016
Last Updated
March 11, 2020
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02681796
Brief Title
Epidural Analgesia Use in Pancreatic Resections
Acronym
E-PRO I
Official Title
Epidural Analgesia Use in Pancreatic Resections
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 7, 2016 (Actual)
Primary Completion Date
February 7, 2020 (Actual)
Study Completion Date
February 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Pancreas, Cancer of the Pancreas, Pancreas Cancer, Pancreas Neoplasms, Pancreatic Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study: Bupivacaine Epidural + standard of care pain regimen
Arm Type
Experimental
Arm 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
Arm Title
Control: Standard of care pain regimen
Arm Type
No Intervention
Arm 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
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Primary Outcome Measure Information:
Title
Total consumption of morphine or morphine-equivalent in patients undergoing pancreatic resections in the control group compared with the study group
Description
-Will be assessed every 24 hours
Time Frame
First 72 hours after surgery
Secondary Outcome Measure Information:
Title
Effect of epidural analgesia during the initial post-operative period as measured by total intraoperative fluid volume
Time Frame
During surgery
Title
Benefit of epidural analgesia as measured by the reduction of persistent post-surgical pain (PPSP) after the operation
Description
-Quantitative sensory testing will be performed on the abdomen in close proximity to the surgical incision
Time Frame
Up to 6 weeks post-surgery
Title
Benefit of epidural analgesia as measured by time to tumor recurrence
Time Frame
Up to 2 years post surgery
Title
Benefit of epidural analgesia as measured by disease-free survival
Time Frame
Up to 2 years post surgery
Title
Benefit of epidural analgesia as measured by overall survival
Time Frame
Up to 2 years post surgery
Title
Rate of delirium in the control group compared with the study group
Description
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
Time Frame
First 72 hours after surgery
Title
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
Title
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
Title
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
Title
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
Title
Effect of epidural analgesia during the initial post-operative period as measured by first bowel movement
Time Frame
Up to 72 hours post surgery
Title
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
Title
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
Title
Effect of epidural analgesia during the initial post-operative period as measured by relative ratios of blood level inflammatory markers
Description
-Specifically interleukin-1-beta (IL-1B), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-a), and interleukin 10 (IL-10) biomarkers
Time Frame
Up to 6 weeks post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bottros, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29374667
Citation
Pak LM, Haroutounian S, Hawkins WG, Worley L, Kurtz M, Frey K, Karanikolas M, Swarm RA, Bottros MM. Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial. BMJ Open. 2018 Jan 26;8(1):e018787. doi: 10.1136/bmjopen-2017-018787.
Results Reference
derived
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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Epidural Analgesia Use in Pancreatic Resections

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