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NCT02793947 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures
A Phase 4 study, sponsored by University of Iowa.
- Completed
- Registry status
- Phase 4
- Development phase
- 102
- Enrollment target
NCT02793947: Completed Phase 4 study, sponsored by University of Iowa.
NCT02793947 is a Phase 4 study that has completed, run by University of Iowa. The registered enrollment target is 102 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02793947, a Phase 4 study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 102 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of a peri-incisional multimodal injection for post-operative pain control following operative management of femur fractures. Enrolled subjects will be prospectively randomized into either the peri-incisional injection or control cohorts. Patients will be treated with standard of care surgical techniques by the treating orthopaedic surgeon for the patient's specific fracture pattern. The patients randomized into the injection cohort will receive an intra-operative injection with 400 mg ropivacaine, 0.6 mg epinephrine, 5 mg and morphine into the local superficial and deep peri-incisional tissues while under general anesthesia. Visual analog pain scores will be collected every 4 hours after surgery for the first two post-operative days. Total narcotic consumption will also be recorded over eight hour intervals for the first two post-operative days. Medication related side effects will be monitored. The investigators hypothesize that the peri-incisional injection cohort will demonstrate an improved pain profile and utilize less parenteral narcotic analgesia in the early post-operative period.
Primary Outcome
Patients will describe their current level of comfort on a 10 point scale while at rest. Zero corresponds to "no pain" and ten corresponds to "the most extreme possible pain." Visual analog scores will be collected by nursing staff who are blinded to the treatment allocation.
Interventions
- DRUG Epinephrine
- DRUG Ropivacaine
- DRUG Morphine
- DRUG 0.9% sodium chloride solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-08 |
| Phase | Phase 4 |
What the finished NCT02793947 record still lists
NCT02793947 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Epinephrine is the first listed.
NCT02793947 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02793947 about?
NCT02793947 is a clinical study titled "Efficacy of Peri-Incisional Multimodal Drug Injection Following Operative Management of Femur Fractures". The purpose of this study is to determine the efficacy and safety of a peri-incisional multimodal injection for post-operative pain control following operative management of femur fractures. Enrolled subjects will be prospectively randomized into either the peri-incisional injection or control cohor...
What is the current status of trial NCT02793947?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 102 participants. The study started on 2015-05. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02793947?
The interventions under investigation include: Epinephrine (DRUG), Ropivacaine (DRUG), Morphine (DRUG), 0.9% sodium chloride solution (DRUG).
Who is sponsoring clinical trial NCT02793947?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02793947's enrollment target sits among peer trials
102 764th of 2000 higher than 1,235 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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