Patient-Titrated Automated Intermittent Boluses of Local Anesthetic vs. a Continuous Infusion Via… (NCT05091905) | Clinical Trial Compass
By InvitationPhase 4
Patient-Titrated Automated Intermittent Boluses of Local Anesthetic vs. a Continuous Infusion Via a Perineural Catheter for Postoperative Analgesia
United States140 participantsStarted 2022-02-14
Plain-language 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 \[dual primary end points\].
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares two ways of delivering a nerve block after surgery — automated boluses versus a continuous infusion — and I'm already scheduled for surgery; is one of these methods something my care team would normally consider for my type of procedure, and does participating in this trial change anything about my standard pain management plan?
2Since this is a Phase 4 trial, does that mean both delivery methods are already approved and in routine use, and is there anything about this specific comparison that still carries uncertainty around safety or effectiveness I should know about?
3The trial is enrolling by invitation only — what would make my doctor decide to invite me to participate, and if I'm not invited, does that mean one of the two approaches is already the plan for my surgery?
4The study is measuring pain levels on the first day after surgery and how long the local anesthetic needs to be given — based on what's already known, is there any early signal that one method controls pain better or reduces how long I'd need the nerve block catheter?
5How much would being in this trial affect my recovery experience in practical terms, such as how often my pain is assessed, whether I'd have more equipment attached, or whether I could still make choices about my own pain relief?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.