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Completed NCT05091905

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

Conditions: Pain, Acute Postoperative, Trauma Injury

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 60
Sponsor: University of California, San Diego

Location: UCSD Medical Center San Diego California

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 \[dual primary end points\].

Eligibility Criteria

Inclusion Criteria: \- 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 Exclusion Criteria: * 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05091905). StuddyBuddy aggregates publicly available trial information.