NCT02681796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 7, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

3.7 years

First QC Date

February 10, 2016

Last Update Submit

March 11, 2020

Conditions

Cancer of PancreasCancer of the PancreasPancreas CancerPancreas NeoplasmsPancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • 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

    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

  • +9 more secondary outcomes

Study Arms (2)

Study: Bupivacaine Epidural + standard of care pain regimen

EXPERIMENTAL

-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

Control: Standard of care pain regimen

NO INTERVENTION

-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

Interventions

BupivacaineDRUG
Study: Bupivacaine Epidural + standard of care pain regimen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing pancreatic resection.
  • Age ≥18 years old.
  • Able to understand and sign an Institutional Review Board (IRB)-approved informed consent form.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • 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.

    PMID: 29374667DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Michael Bottros, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 12, 2016

Study Start

June 7, 2016

Primary Completion

February 7, 2020

Study Completion

February 7, 2020

Last Updated

March 12, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)