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COMPLETED Phase 4

Efficacy of Hematoma Block on Postoperative Pain After Femoral Intramedullary Rodding: A Randomized Trial

NCT04860856 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the efficacy of an intra-operative, post-fixation fracture hematoma block compared to saline control on postoperative pain control in patients with acute femoral shaft fractures. Our primary outcome measure is visual analog scale (VAS) pain scores which are recorded at regular intervals.

Conditions Studied

Interventions

  • DRUG Normal Saline
  • DRUG 0.5% ropivacaine

Study Locations (1)

Ohio

  • University of Cincinnati College of Medicine — Cincinnati

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2019-08-17
Est. Completion 2023-02-07
Phase Phase 4

Sponsor

University of Cincinnati

179 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04860856

The ClinicalTrials.gov registry entry for NCT04860856 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Cincinnati, which has 179 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Femur Fracture appearing as the primary indexed condition, and to 2 interventions — of which Normal Saline is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04860856 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04860856 about?

NCT04860856 is a clinical study titled "Efficacy of Hematoma Block on Postoperative Pain After Femoral Intramedullary Rodding: A Randomized Trial". The purpose of this study is to evaluate the efficacy of an intra-operative, post-fixation fracture hematoma block compared to saline control on postoperative pain control in patients with acute femoral shaft fractures. Our primary outcome measure is visual analog scale (VAS) pain scores which are r...

What is the current status of trial NCT04860856?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 88 participants. The study started on 2019-08-17. Estimated completion is 2023-02-07.

What conditions does trial NCT04860856 study?

This clinical trial studies the following conditions: Femur Fracture. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04860856?

The interventions under investigation include: Normal Saline (DRUG), 0.5% ropivacaine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04860856?

This trial is sponsored by University of Cincinnati, which has 179 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04860856 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial