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NCT07212114 · ClinicalTrials.gov registry record · Phase 3
Efficacy of EXPAREL vs. Bupivacaine
A Phase 3 study of Total Ankle Arthroplasty and Postsurgical Analgesia, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 104
- Enrollment target
- 1
- Study location
NCT07212114: Recruiting Phase 3 study of Total Ankle Arthroplasty and Postsurgical Analgesia, sponsored by Emory University.
NCT07212114 is a Phase 3 study of Total Ankle Arthroplasty and Postsurgical Analgesia that is actively recruiting participants, run by Emory University. The registered enrollment target is 104 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07212114, a Phase 3 study of Total Ankle Arthroplasty and Postsurgical Analgesia, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 104 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical study is to learn about pain management strategies in subjects undergoing total ankle replacement. arthroplasty surgery The primary objective is to compare the magnitude of the analgesic effect following a single dose injection of EXPAREL vs. 0.25% bupivacaine (HCl). Secondary objectives are to: Compare the total opioid consumption (in oral morphine equivalents) from 0 to 96 hours following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl * Compare the time to first opioid consumption following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl * Assess the safety of EXPAREL vs. 0.25% bupivacaine HCl * Evaluate subject satisfaction with pain management following a single-dose injection of EXPAREL vs. 0.25% bupivacaine hydrochloride (HCl) * Compare clinical performance from Preoperative status to 3- and 12- months postoperatively
Primary Outcome
To measure this, the Area under the curve (AUC) of the Numeric Rating Scale (NRS) for both groups will be compared. The subjects will be asked to rate their worst or average pain on a scale of 0 (no pain) - 10 (worst possible pain) on numerous time points, starting upon arrival in the Post-Anesthesia Care Unit (PACU)
Conditions Studied
Interventions
- DRUG EXPAREL
- DRUG 0.25% bupivacaine (HCl): 50 ml
- DRUG 0.25% bupivacaine (HCl): 30 ml
Study Locations (1)
Georgia
- Emory University Orthopaedic Hospital Musculoskeletal Institute (MSK) - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2025-11-17 |
| Est. Completion | 2029-08 |
| Phase | Phase 3 |
What NCT07212114 shows while recruiting
NCT07212114 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Total Ankle Arthroplasty appearing as the primary indexed condition, and to 3 interventions - of which EXPAREL is the first listed.
NCT07212114 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT07212114 about?
NCT07212114 is a clinical study titled "Efficacy of EXPAREL vs. Bupivacaine". The goal of this clinical study is to learn about pain management strategies in subjects undergoing total ankle replacement. arthroplasty surgery The primary objective is to compare the magnitude of the analgesic effect following a single dose injection of EXPAREL vs. 0.25% bupivacaine (HCl). Secon...
What is the current status of trial NCT07212114?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2025-11-17. Estimated completion is 2029-08.
What conditions does trial NCT07212114 study?
This clinical trial studies the following conditions: Total Ankle Arthroplasty, Postsurgical Analgesia.
What interventions are being tested in trial NCT07212114?
The interventions under investigation include: EXPAREL (DRUG), 0.25% bupivacaine (HCl): 50 ml (DRUG), 0.25% bupivacaine (HCl): 30 ml (DRUG).
Who is sponsoring clinical trial NCT07212114?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07212114 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT07212114's enrollment target sits among peer trials
104 1672nd of 2000 higher than 327 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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