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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04157075
The ClinicalTrials.gov registry entry for NCT04157075 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bupivacaine is the first listed.
NCT04157075 reports 0 study locations.
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.
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