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ENROLLING BY INVITATION
NCT05091905
PHASE4

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

Sponsor: University of California, San Diego

View on ClinicalTrials.gov

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 \[dual primary end points\].

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2022-02-14

Completion Date

2026-12

Last Updated

2026-03-23

Healthy Volunteers

No

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.

Locations (1)

UCSD Medical Center

San Diego, California, United States