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NCT06271265 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery
A Phase 1 study of Postoperative Pain, sponsored by Pacira Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 5
- Study locations
NCT06271265 is a Phase 1 study of Postoperative Pain that is actively recruiting participants, run by Pacira Pharmaceuticals. The registered enrollment target is 48 participants, below the 231-participant average among 63 other Postoperative Pain trials with a reported enrollment target (79% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT06271265, a Phase 1 study of Postoperative Pain, is actively recruiting participants, sponsored by Pacira Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 5
- Study locations
Study Summary
This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local infiltration analgesia (LIA).
Conditions Studied
Interventions
- DRUG EXPAREL
- DRUG bupivacaine
Study Locations (5)
Indiana
- Indiana University Health, Riley Hospital For Children - Indianapolis
Missouri
- St. Louis Children's Hospital (SLCH) - St Louis
North Carolina
- Duke University Health System - Durham
Oklahoma
- University of Oklahoma (OU) - Medical Center - The Children's Hospital - Oklahoma City
Texas
- The University of Texas Health Science Center at Houston (UTHSC-H) - McGovern Medical School - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2024-03-29 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06271265
The ClinicalTrials.gov registry entry for NCT06271265 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 231-participant average among 63 other Postoperative Pain trials with a reported enrollment target (79% lower). The listed sponsor is Pacira Pharmaceuticals, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which EXPAREL is the first listed.
NCT06271265 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Indiana, Missouri, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06271265 about?
NCT06271265 is a clinical study titled "Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery". This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local ...
What is the current status of trial NCT06271265?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2024-03-29. Estimated completion is 2027-01.
What conditions does trial NCT06271265 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT06271265?
The interventions under investigation include: EXPAREL (DRUG), bupivacaine (DRUG).
Who is sponsoring clinical trial NCT06271265?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06271265 being conducted?
This trial has 5 study locations across Indiana, Missouri, North Carolina, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.