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NCT05374499 · ClinicalTrials.gov registry record · Phase 4
Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions
A Phase 4 study of Postoperative Pain, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 4
- Development phase
- 73
- Enrollment target
- 1
- Study location
NCT05374499: Completed Phase 4 study of Postoperative Pain, sponsored by University of Southern California.
NCT05374499 is a Phase 4 study of Postoperative Pain that has completed, run by University of Southern California. The registered enrollment target is 73 participants, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05374499, a Phase 4 study of Postoperative Pain, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 73 participants
- Enrollment target
- 1
- Study location
Study Summary
The most prevalent complaint after third molar extractions is pain. There have been many modalities and regimens developed to manage post-operative pain, such as modifications in surgical techniques, locally-applied medicaments, and oral analgesics. Recently, liposomal bupivacaine (Exparel) has been FDA approved for single-dose infiltration in the oral cavity in adults and children (6 years or older) to produce extended postsurgical local anesthesia. We hypothesize that the administration of liposomal bupivacaine (Exparel) at the end of third molar extractions will decrease postoperative pain and decrease narcotic use for pain management.
Primary Outcome
At home questionnaire with a numerical scale (0 - 10 with 0 being least amount of pain and 10 being most amount of pain), to be completed each morning and evening for four days post-operative. Then the cumulative pain rating using the numeric rating scale area under the curve over 96 hours (0 - 960 with 0 being least amount of pain over 96 hours and 960 being the most amount of pain over 96 hours), scaled at the hour-level, is calculated using the trapezoidal method in the caTools package in R,
Conditions Studied
Interventions
- DRUG Liposomal bupivacaine
- DRUG 0.5% bupivacaine with 1:100,000 epinephrine
Study Locations (1)
California
- Herman Ostrow School of Dentistry of USC - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2024-05-01 |
| Phase | Phase 4 |
What the finished NCT05374499 record still lists
NCT05374499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which Liposomal bupivacaine is the first listed.
NCT05374499 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05374499 about?
NCT05374499 is a clinical study titled "Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions". The most prevalent complaint after third molar extractions is pain. There have been many modalities and regimens developed to manage post-operative pain, such as modifications in surgical techniques, locally-applied medicaments, and oral analgesics. Recently, liposomal bupivacaine (Exparel) has been...
What is the current status of trial NCT05374499?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 73 participants. The study started on 2022-09-01. Estimated completion is 2024-05-01.
What conditions does trial NCT05374499 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT05374499?
The interventions under investigation include: Liposomal bupivacaine (DRUG), 0.5% bupivacaine with 1:100,000 epinephrine (DRUG).
Who is sponsoring clinical trial NCT05374499?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05374499 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05374499's enrollment target sits among peer trials
73 82nd of 120 higher than 39 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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