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

March 11, 2020 updated by: Washington University School of Medicine
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: First 72 hours after surgery
-Will be assessed every 24 hours
First 72 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of epidural analgesia during the initial post-operative period as measured by total intraoperative fluid volume
Time Frame: During surgery
During surgery
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
Up to 6 weeks post-surgery
Benefit of epidural analgesia as measured by time to tumor recurrence
Time Frame: Up to 2 years post surgery
Up to 2 years post surgery
Benefit of epidural analgesia as measured by disease-free survival
Time Frame: Up to 2 years post surgery
Up to 2 years post surgery
Benefit of epidural analgesia as measured by overall survival
Time Frame: Up to 2 years post surgery
Up to 2 years post surgery
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
First 72 hours after surgery
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
Up to 72 hours post surgery
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
Up to 72 hours post surgery
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
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
Time Frame: Up to 72 hours post surgery
Up to 72 hours post surgery
Effect of epidural analgesia during the initial post-operative period as measured by first bowel movement
Time Frame: Up to 72 hours post surgery
Up to 72 hours post surgery
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
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
Time Frame: Up to 72 hours post surgery
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
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
Up to 6 weeks post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Bottros, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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