Epidural Analgesia Use in Pancreatic Resections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-07

Study Completion Date

2020-02-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer of Pancreas Cancer of the Pancreas Pancreas Cancer Pancreas Neoplasms Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bupivacaine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No