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NCT05972681 · ClinicalTrials.gov registry record · Phase 4
The PAIN (Pelvic Area Injection for Numbness) Study
A Phase 4 study of Vaginal Laceration During Delivery, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05972681: Recruiting Phase 4 study of Vaginal Laceration During Delivery, sponsored by Montefiore Medical Center.
NCT05972681 is a Phase 4 study of Vaginal Laceration During Delivery that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05972681, a Phase 4 study of Vaginal Laceration During Delivery, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Postpartum pain can interfere with patient's ability to care for themselves, and their newborn, and untreated pain is associated with risk of greater opioid use, postpartum depression, and development of persistent pain. The research hypothesis of this study is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain and improve women's overall well-being and satisfaction. The objective of this study is to determine if prolonged analgesia and higher rate of maternal satisfaction are found when bupivacaine with epinephrine infiltration is used for perineal repair as compared to sham injection in patients with pre-existing effective epidural analgesia at time of perineal laceration repair.
Primary Outcome
The average time to first analgesic (TFA), in minutes, will be evaluated as the duration interval from injection to administration of the first analgesic, as applicable.
Conditions Studied
Interventions
- DRUG Bupivacaine
- DRUG Epinephrine
- OTHER Sham normal saline arm
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-04-08 |
| Est. Completion | 2026-07 |
| Phase | Phase 4 |
What NCT05972681 shows while recruiting
NCT05972681 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Vaginal Laceration During Delivery appearing as the primary indexed condition, and to 3 interventions - of which Bupivacaine is the first listed.
NCT05972681 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05972681 about?
NCT05972681 is a clinical study titled "The PAIN (Pelvic Area Injection for Numbness) Study". Postpartum pain can interfere with patient's ability to care for themselves, and their newborn, and untreated pain is associated with risk of greater opioid use, postpartum depression, and development of persistent pain. The research hypothesis of this study is that adding a locally injected analges...
What is the current status of trial NCT05972681?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2025-04-08. Estimated completion is 2026-07.
What conditions does trial NCT05972681 study?
This clinical trial studies the following conditions: Vaginal Laceration During Delivery.
What interventions are being tested in trial NCT05972681?
The interventions under investigation include: Bupivacaine (DRUG), Epinephrine (DRUG), Sham normal saline arm (OTHER).
Who is sponsoring clinical trial NCT05972681?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05972681 being conducted?
This trial has 1 study location across New York. 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 NCT05972681's enrollment target sits among peer trials
100 770th of 2000 higher than 1,149 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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