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NCT04157075 · ClinicalTrials.gov registry record · Early Phase 1
Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy
A Early Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 180
- Enrollment target
NCT04157075: Completed Early Phase 1 study, sponsored by Johns Hopkins University.
NCT04157075 is a Early Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 180 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (240% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04157075, a Early Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 180 participants
- Enrollment target
Study Summary
This is proof of concept, phase I randomized controlled trial studying a short acting non-opioid anesthetic, bupivacaine to improve post-operative pain in gynecologic surgery patients. Patients who are undergoing minimally invasive (laparoscopic or robotic) hysterectomy will be randomized to receive no uterosacral injection, normal saline uterosacral injection, or 0.25% bupivacaine uterosacral injection just prior to colpotomy (incision around the cervix and removal of uterus) during minimally invasive hysterectomy.
Primary Outcome
Total morphine equivalents of opioids in the first 7 days after surgery will be assessed to look for a statistically significant difference
Interventions
- DRUG Bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2022-10-15 |
| Phase | Early Phase 1 |
What the finished NCT04157075 record still lists
NCT04157075 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (240% higher).
The record links to 0 conditions, and to 1 intervention - of which Bupivacaine is the first listed.
NCT04157075 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04157075 about?
NCT04157075 is a clinical study titled "Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy". This is proof of concept, phase I randomized controlled trial studying a short acting non-opioid anesthetic, bupivacaine to improve post-operative pain in gynecologic surgery patients. Patients who are undergoing minimally invasive (laparoscopic or robotic) hysterectomy will be randomized to receive...
What is the current status of trial NCT04157075?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 180 participants. The study started on 2021-03-15. Estimated completion is 2022-10-15.
What interventions are being tested in trial NCT04157075?
The interventions under investigation include: Bupivacaine (DRUG).
Who is sponsoring clinical trial NCT04157075?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04157075's enrollment target sits among peer trials
180 75th of 2000 higher than 1,925 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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