NCT05091905|CompletedPhase 4FDA Drug
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Sponsor study identifier
interventional
60
1 country
1
Study Start
March 22, 2022
Actual (reported)Primary Completion
March 18, 2026
Actual (reported)Study Completion
March 21, 2026
Actual (reported)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 \[dual primary end points\].
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 21, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2021
Actual (reported)October 25, 2021
Actual (reported)March 22, 2022
Actual (reported)March 18, 2026
Actual (reported)March 21, 2026
Actual (reported)Average Pain queried on First postoperative day
Rated 0-10 on numeric rating scale the average pain from the recovery room until the data collection call (0=no pain, 10=worst imaginable pain)
Postoperative day 1
Duration of local anesthetic administration
The duration of treatment from when the infusion pump was initially turned on until the local anesthetic reservoir was exhausted \[recorded by the infusion pump memory\]
The first 8 days postoperatively
Worst pain
Each of 9 days postoperatively
Average pain
Each of 9 days postoperatively
Least pain
Each of 9 days postoperatively
Current pain
Each of 9 days postoperatively
Opioid consumption
Each of 9 days postoperatively
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).
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).
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.
UCSD Medical Center
San Diego, California, 92103, United States
Brian M Ilfeld, MD, MS
University of California, San Diego
60 participants (actual enrollment reported by the registry).
First Submitted
October 11, 2021
First Posted
October 25, 2021
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
March 22, 2022
Actual (reported)Primary Completion
March 18, 2026
Actual (reported)Study Completion
March 21, 2026
Actual (reported)Last Updated
August 24, 2026
Record last verified: 2026-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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