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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: Recruiting Phase 1 study of Postoperative Pain, sponsored by Pacira Pharmaceuticals.
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 120 other Postoperative Pain trials with a reported enrollment target (79% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
• Area under the plasma concentration-versus-time curve (AUClast and AUC0-inf)
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 |
What NCT06271265 shows while recruiting
NCT06271265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (79% lower).
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 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06271265's enrollment target sits among peer trials
48 104th of 120 higher than 17 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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