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Perineural Local Anesthetic Administration With a Continuous Infusion Versus Automatic Intermittent Boluses

NCT04458467 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2022-06-30

Study results available
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Summary

This will be a randomized comparison of continuous local anesthetic infusion with patient controlled boluses (PCA) to automated boluses with PCA for continuous popliteal sciatic nerve blocks. The goal will be to determine the relationship between method of local anesthetic administration (continuous with PCA initiated at discharge vs. intermittent dosing with PCA with a 5-hour delay) for continuous peripheral nerve block and the resulting pain control and duration of analgesia.

Conditions

  • Pain, Acute
  • Anesthesia, Local
  • Trauma Injury

Interventions

DEVICE

Continuous Infusion

A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.

DEVICE

Automated Intermittent Boluses

Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).

Sponsors & Collaborators

Principal Investigators

  • Brian M Ilfeld, MD, MS · University California San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2021-03-12
Completion
2021-03-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT04458467 on ClinicalTrials.gov