Patient-Titrated Automated Intermittent Boluses of Local Anesthetic vs. a Continuous Infusion Via a Perineural Catheter for Postoperative Analgesia
Enrolling by invitation · Phase 4
Conditions studied: Pain, Acute Postoperative, Trauma Injury
In brief
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 facts
- Study ID
- NCT05091905
- Run by
- University of California, San Diego
- People needed
- 140
- Starts
- 2022-02-14
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-03-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- UCSD Medical Center — San Diego, California, United States
Full record on ClinicalTrials.gov
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