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

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 Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Pancreas Cancer; Pancreas Neoplasms; Cancer of Pancreas; Cancer of the Pancreas
• Intervention / Treatment: Drug: Bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	First 72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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	Up to 6 weeks post-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 disease-free survival		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	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	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 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 first bowel movement		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 incidence of deep venous thromboembolism/pulmonary embolism		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	-Specifically interleukin-1-beta (IL-1B), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-a), and interleukin 10 (IL-10) biomarkers	Up to 6 weeks post-surgery

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2016
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): February 7, 2020

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: February 10, 2016
• First Posted (Estimate): February 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 201506125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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