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Patient-Titrated Automated Intermittent Boluses of Local Anesthetic vs. a Continuous Infusion Via a Perineural Catheter for Postoperative Analgesia

NCT05091905 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-03-23

No results posted yet for this study

Summary

This will be a randomized comparison of continuous local anesthetic infusion with patient controlled boluses (PCA) to patient-titratable automated boluses with patient controlled boluses (PCA) for both infraclavicular and popliteal-sciatic perineural catheters. The overall goal is to determine the relationship between method of local anesthetic administration (continuous with PCA vs. titratable intermittent dosing with PCA) for these two perineural catheter locations and the resulting pain control. The investigators hypothesize that, compared with a traditional fixed, continuous basal infusion initiated prior to discharge, perineural local anesthetic administered with titratable automated boluses at a lower dose and a 5-hour delay following discharge will (1) provide at least noninferior analgesia during the period that both techniques are functioning; and, (2) will result in a longer overall duration of administration \[dual primary end points\].

Conditions

  • Pain, Acute Postoperative
  • Trauma Injury

Interventions

DRUG

Continuous Infusion of ropivacaine 0.2%

Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr popliteal-sciatic and 8 mL/hr infraclavicular, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.

DRUG

Titratable Automated Intermittent Boluses of ropivacaine 0.2%

Patients will receive patient-titratable intermittent boluses of Ropivacaine 0.2% (8 mL popliteal-sciatic or 11 mL infraclavicular automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout). In addition, the infusion pump will be set in a "pause" mode that delays initiation of the automated bolus doses by 5 hours (this can be over-ridden by patients if they would like to initiate their perineural infusion earlier than 5 hours). Lastly, subjects will be able to titrate the volume of their automated bolus up or down within the range of 1-16 mL.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2026-11-30
Completion
2026-12-31
FDA Drug
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 NCT05091905 on ClinicalTrials.gov