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NCT04032327 · ClinicalTrials.gov registry record · Phase 2
Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy
A Phase 2 study of Postoperative Pain, sponsored by Walter Reed National Military Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT04032327: Completed Phase 2 study of Postoperative Pain, sponsored by Walter Reed National Military Medical Center.
NCT04032327 is a Phase 2 study of Postoperative Pain that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 120 participants, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04032327, a Phase 2 study of Postoperative Pain, has completed, sponsored by Walter Reed National Military Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
Effective post-surgical pain management is a crucial component of a patient's postoperative course following posterior colporrhaphy. Narcotics are the cornerstone for postoperative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks. The colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute post-operative pain; however, literature regarding this medication specific to Urogynecology and Gynecology is limited. The investigators propose a prospective, randomized, double blind, trial with 120 subjects recruited from the Walter Reed National Military Medical Center (WRNMMC) Urogynecology Clinic to study postsurgical pain control after posterior repair. There will be two arms in the study; one arm with bupivacaine alone and a second arm with bupivacaine mixed with Exparel®(extended-release, liposomal bupivacaine) injected vaginally in patients undergoing posterior colporrhaphy. Subjects will be randomized to receive either 20 milliliter (mL) of plain bupivacaine or 20mL (10ml+10ml) mixture of bupivacaine plus Exparel®. The primary objective of the trial will be to evaluate the postsurgical vaginal pain using a visual analog pain scale at days 1, 2, 3 post-procedure. All subjects will have acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control regardless of assignment, which is the usual postoperative pain control regimen. The investigators hypothesize a 30% difference in post-operative pain measurements between the two groups. Additional objectives of this study are to evaluate total medication usage on days 1, 2 and 3 and any post-operative voiding and defecatory dysfunction, comparing the two groups
Primary Outcome
Patients will be asked on postoperative day (POD) 1 to provide numerical values regarding vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)
Conditions Studied
Interventions
- DRUG Bupivacaine
- DRUG Exparel plus plain bupivacaine
Study Locations (1)
Maryland
- Walter Reed National Military Medical Center (WRNMMC) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2020-08-25 |
| Phase | Phase 2 |
What the finished NCT04032327 record still lists
NCT04032327 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 231-participant average among 120 other Postoperative Pain trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which Bupivacaine is the first listed.
NCT04032327 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04032327 about?
NCT04032327 is a clinical study titled "Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy". Effective post-surgical pain management is a crucial component of a patient's postoperative course following posterior colporrhaphy. Narcotics are the cornerstone for postoperative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks. The colorec...
What is the current status of trial NCT04032327?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2018-07-01. Estimated completion is 2020-08-25.
What conditions does trial NCT04032327 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT04032327?
The interventions under investigation include: Bupivacaine (DRUG), Exparel plus plain bupivacaine (DRUG).
Who is sponsoring clinical trial NCT04032327?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04032327 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04032327's enrollment target sits among peer trials
120 45th of 120 higher than 74 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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