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NCT04428320
The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery
NA trial testing Pelvic floor injection in Pelvic Floor Prolapse in 140 participants. Status unknown.
21 May 2022
Quick facts
| Lead sponsor | The Cooper Health System |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 21 May 2020 |
| Primary completion | 21 May 2022 |
| Estimated completion | 21 May 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Pelvic floor injection
Conditions studied
- Pelvic Floor Prolapse — all drugs for Pelvic Floor Prolapse →
- Surgery — all drugs for Surgery →
- Pain, Postoperative — all drugs for Pain, Postoperative →
Sponsor
The Cooper Health System — full company profile →
Who can join
18 and older, female only, with Pelvic Floor Prolapse or Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive bilateral trans-vaginal pelvic floor muscle injections with bupivacaine or no injection (standard of care) as a part of their surgical pain control
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04428320
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pelvic Floor Prolapse
Currently open trials in the same condition.
- NCT04547816 — Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse · Phase 3 · recruiting
Other The Cooper Health System trials
Trials by the same sponsor.
- NCT07296120 — RSV Vaccine Response in Stem Cell and CAR-T Therapy Recipients · Phase 4 · not yet recruiting
- NCT07042048 — Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization · NA · not yet recruiting
- NCT06462781 — Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment Phase 1 · Phase 1 · completed
- NCT05974423 — Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation After Labrum Repair · Phase 4 · unknown
- NCT06398366 — Cardiac Abnormalities in Stroke Prevention and Risk of Recurrence · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04428320 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Cooper Health System
- Last refreshed: 11 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04428320.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing