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NCT04429022 · ClinicalTrials.gov registry record · Phase 3
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
A Phase 3 study, sponsored by State University of New York at Buffalo.
- Completed
- Registry status
- Phase 3
- Development phase
- 68
- Enrollment target
NCT04429022 is a Phase 3 study that has completed, run by State University of New York at Buffalo. The registered enrollment target is 68 participants.
The verdict
NCT04429022, a Phase 3 study, has completed, sponsored by State University of New York at Buffalo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 68 participants
- Enrollment target
Study Summary
Hysterectomy is the most common major gynecologic surgery performed in the US and is performed for a variety of indications including malignancy, pelvic mass, endometriosis, leiomyoma, and pelvic organ prolapse. The traditional regimen for pain control post-operatively is opioid-based however in light of the opioid epidemic, a transition to non-opioid pain medication regimens is desired by both physicians and patients alike. The goal of this study is to develop a multimodal non-opioid pain medication regimen that minimizes postoperative opioid use after robotic assisted total laparoscopic hysterectomy. Historical controls from January, 2017 to January, 2020 will be compared to our treatment arm from November, 2020 to November, 2022. Included in our treatment protocol is paracervical block and local ropivacaine at abdominal incision sites at surgical start, gabapentin and acetaminophen preoperatively and postoperatively, and celecoxib postoperatively. Opioid use will be measured 0-3 h postop and 3-24h postop (as surrogate marker of time spent recovering in the Post Anesthesia Care Unit (PACU), and during the full length of hospital stay); pain scores will additionally be measured.
Interventions
- DRUG Acetaminophen
- DRUG Ketorolac
- DRUG Celecoxib
- DRUG Gabapentin
- PROCEDURE Paracervical block with ropivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2020-11-24 |
| Est. Completion | 2022-05-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04429022
The ClinicalTrials.gov registry entry for NCT04429022 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York at Buffalo, which has 243 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT04429022 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04429022 about?
NCT04429022 is a clinical study titled "Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy". Hysterectomy is the most common major gynecologic surgery performed in the US and is performed for a variety of indications including malignancy, pelvic mass, endometriosis, leiomyoma, and pelvic organ prolapse. The traditional regimen for pain control post-operatively is opioid-based however in lig...
What is the current status of trial NCT04429022?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 68 participants. The study started on 2020-11-24. Estimated completion is 2022-05-31.
What interventions are being tested in trial NCT04429022?
The interventions under investigation include: Acetaminophen (DRUG), Ketorolac (DRUG), Celecoxib (DRUG), Gabapentin (DRUG), Paracervical block with ropivacaine (PROCEDURE).
Who is sponsoring clinical trial NCT04429022?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
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