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Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery.

NCT03307174 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-05-12

Study results available
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Summary

Epidurals are an effective means for providing neuraxial anesthesia and analgesia. Prior studies in labor epidurals have demonstrated that a programmed intermittent bolus application of local anesthesia can improve pain control by reducing the amount of local anesthetic required as well as improve patient satisfaction when compared to continuous epidural infusions. The effects of programmed intermittent bolus of epidural local anesthetics compared to continuous epidural infusions in a surgical setting have yet to be elucidated. Our goal is to evaluate the use of programmed intermittent bolus compared to continuous epidural infusion in a surgical patient population. We plan to enroll patients already undergoing abdominal surgeries including colorectal, gynecologic, surgical oncology, urological where epidural anesthesia can be employed. The primary endpoints of the study will be the total local anesthetic consumption and total opioid consumption as surrogate markers for the quality of epidural anesthesia. Secondary endpoints are pain scores and functional measurements, patient satisfaction, and incidence of hypotension.

Conditions

  • Pain, Acute

Interventions

DRUG

Bupivacaine

DRUG

Fentanyl

Sponsors & Collaborators

Principal Investigators

  • Matthias Behrends, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-14
Primary Completion
2019-02-28
Completion
2019-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03307174 on ClinicalTrials.gov