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NCT05139030 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty
A Phase 3 study of Knee Osteoarthritis and Pain Management, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 167
- Enrollment target
- 6
- Study locations
NCT05139030: Completed Phase 3 study of Knee Osteoarthritis and Pain Management, sponsored by Pacira Pharmaceuticals.
NCT05139030 is a Phase 3 study of Knee Osteoarthritis and Pain Management that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 167 participants, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (45% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05139030, a Phase 3 study of Knee Osteoarthritis and Pain Management, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 167 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of the study is to compare magnitude of postsurgical analgesic effect in different groups following a single dose of study drug when administered via adductor canal block in subjects undergoing primary unilateral total knee arthroplasty.
Primary Outcome
The numeric rating scale pain intensity scores ranging from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, from 0 to 96 hours post-surgery. For each subject, the area under the curve was derived using the trapezoidal rule on the pain scores adjusted for opioid pain medication using the observed and imputed values. Area under the curve started with the first pain assessment obtained after surgery and use all subsequent pain assessments up to 96 hours post-surgery. Pain sco
Conditions Studied
Interventions
- DRUG Bupivacaine Hydrochloride
- DRUG bupivacaine liposome injectable suspension
Study Locations (6)
Texas
- First Surgical Hospital - Bellaire
- HD Research- Legent Orthopedic Hospital - Carrollton
- Endeavor Clinical Trials - San Antonio
Arkansas
- Woodland International Research Group - Little Rock
California
- Lotus Clinical Research - Pasadena
Ohio
- Midwest Clinical Research Center, LLC - Dayton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2022-01-18 |
| Est. Completion | 2022-07-11 |
| Phase | Phase 3 |
What the finished NCT05139030 record still lists
NCT05139030 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (45% lower).
The record links to 2 conditions, with Knee Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which Bupivacaine Hydrochloride is the first listed.
NCT05139030 lists 6 locations in 4 states (Texas, Arkansas, California).
Frequently Asked Questions
What is clinical trial NCT05139030 about?
NCT05139030 is a clinical study titled "Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty". The purpose of the study is to compare magnitude of postsurgical analgesic effect in different groups following a single dose of study drug when administered via adductor canal block in subjects undergoing primary unilateral total knee arthroplasty.
What is the current status of trial NCT05139030?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 167 participants. The study started on 2022-01-18. Estimated completion is 2022-07-11.
What conditions does trial NCT05139030 study?
This clinical trial studies the following conditions: Knee Osteoarthritis, Pain Management.
What interventions are being tested in trial NCT05139030?
The interventions under investigation include: Bupivacaine Hydrochloride (DRUG), bupivacaine liposome injectable suspension (DRUG).
Who is sponsoring clinical trial NCT05139030?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05139030 being conducted?
This trial has 6 study locations across Arkansas, California, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Knee Osteoarthritis
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 NCT05139030's enrollment target sits among peer trials
167 31st of 101 higher than 71 of 101 other Knee Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Knee Osteoarthritis 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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