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

NCT05091905 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: Patient-Titrated Boluses cPNB
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• 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

Study Arms (2)

Continuous Infusion

ACTIVE COMPARATOR

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).

Drug: Continuous Infusion of ropivacaine 0.2%

Titratable Automated Boluses

EXPERIMENTAL

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).

Drug: Titratable Automated Intermittent Boluses of ropivacaine 0.2%

Interventions

Continuous Infusion of ropivacaine 0.2% DRUG

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.

Also known as: Perineural local anesthetic infusion

Continuous Infusion

Titratable Automated Intermittent Boluses of ropivacaine 0.2% DRUG

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.

Also known as: Perineural local anesthetic administration

Titratable Automated Boluses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- patients undergoing ulnar and/or radial fracture open reduction internal fixation or painful foot and/or ankle surgery with a planned infraclavicular or popliteal sciatic perineural catheter, respectively, for postoperative analgesia

You may not qualify if:

• daily opioid use within the previous 4 weeks
• clinical neuro-muscular deficit of either the brachial plexus (infraclavicular) or sciatic nerve (sciatic catheters) and its branches and/or innervating muscles
• morbid obesity \[body mass index \> 35 kg/m2\]
• surgery outside of the ipsilateral sciatic and saphenous nerve distributions for sciatic catheters \[e.g., iliac crest bone graft\]
• pregnancy
• incarceration

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Accidental Injuries

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Wounds and Injuries

Study Officials

• Brian M Ilfeld, MD, MS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It will be impossible to mask investigators as they program the infusion pumps based on treatment group assignment; it will be impossible to mask participants as they will either be told how to titrate the bolus doses or not; and it will be impossible to mask the outcome assessor as we need to query patients on their daily bolus dose volume to track changes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Model Details: Randomized, Unmasked, Active-Controlled Human Subjects Clinical Trial

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 25, 2021
• Study Start: February 14, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)