Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by State University of New York at Buffalo.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME)
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 |
What the finished NCT04429022 record still lists
NCT04429022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT04429022 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04429022's enrollment target sits among peer trials
68 1796th of 2000 higher than 205 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02044497 · 68 participants · Phase 4
Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients
- NCT03779854 · 68 participants · Phase 2
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
- NCT03821246 · 68 participants · Phase 2
Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy
- NCT04115514 · 68 participants · Phase 2
Treatment of ARDS With Instilled T3
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI