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NCT03875664 · ClinicalTrials.gov registry record · Phase 4
Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy
A Phase 4 study of Postoperative Pain, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT03875664: Completed Phase 4 study of Postoperative Pain, sponsored by Wake Forest University Health Sciences.
NCT03875664 is a Phase 4 study of Postoperative Pain that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 72 participants, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03875664, a Phase 4 study of Postoperative Pain, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
The specific aim of this randomized double-blind clinical trial is to evaluate the effect of intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as measured by visual analog scales (VAS) for patients undergoing surgery for pelvic organ prolapse. Study subjects are randomized to 30 mL of liposomal bupivacaine versus 30 mL of injectable normal saline administered in a standardized technique into the posterior vaginal compartment at the time of posterior repair and/or perineorrhaphy.
Primary Outcome
As measured by a 100 mm Visual Analog Scale (VAS). This scale ranges from 0-100 mm with 0 mm indicating no pain and 100 mm indicating the most pain. The study is powered to detect a decrease in postoperative pain by 20 mm on this scale, which is considered to be a clinically meaningful difference in prior studies. Results will be reported as mean pain scores at each time point (night of surgery, morning and evening for the first 72 hours after surgery, i.e. until postoperative day#3).
Conditions Studied
Interventions
- DRUG Liposomal bupivacaine
- DRUG Placebo - injection
Study Locations (1)
North Carolina
- Women's Center for Pelvic Health - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2018-07-23 |
| Est. Completion | 2019-03-31 |
| Phase | Phase 4 |
What the finished NCT03875664 record still lists
NCT03875664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (69% 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.
NCT03875664 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03875664 about?
NCT03875664 is a clinical study titled "Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy". The specific aim of this randomized double-blind clinical trial is to evaluate the effect of intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as measured by visual anal...
What is the current status of trial NCT03875664?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2018-07-23. Estimated completion is 2019-03-31.
What conditions does trial NCT03875664 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT03875664?
The interventions under investigation include: Liposomal bupivacaine (DRUG), Placebo - injection (DRUG).
Who is sponsoring clinical trial NCT03875664?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03875664 being conducted?
This trial has 1 study location across North Carolina. 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 NCT03875664's enrollment target sits among peer trials
72 83rd of 120 higher than 37 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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