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NCT02967172 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures
A Phase 4 study, sponsored by University of Iowa.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT02967172: Completed Phase 4 study, sponsored by University of Iowa.
NCT02967172 is a Phase 4 study that has completed, run by University of Iowa. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02967172, a Phase 4 study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy and safety of a peri-articular multimodal injection for post-operative pain control following operative management of closed, rotational ankle fractures. Enrolled subjects will be randomized to either receive or not receive intra-operative injections in addition to standard opioid analgesic regimens. 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 a 25cc intra-operative injection with 200 mg ropivacaine, 0.6 mg epinephrine, 5 mg and morphine into the local superficial and deep peri-incisional tissues while under general anesthesia. Total post-operative opioid consumption expressed in morphine equivalent dose will be recorded, including IV and oral opioids. Time in hours from operation conclusion to discharge and discharge disposition (to where the patient is discharged) will also be recorded. Post-operative pain scores will be assessed and recorded in the immediate post-operative period and every 4 hours subsequently until the patient is discharged. Medication related side effects will be monitored. The investigators hypothesize that the injection cohort will have reduced pain scores, lower narcotic requirements, shorter length of stay, and be more likely to discharge to home following surgery.
Primary Outcome
The primary outcome was VAS pain over the first 48 hours postoperatively. Patients reported pain with use of a 100-mm VAS, with 0-mm being no pain and 100-mm being the most extreme pain imaginable. A higher score indicates worse pain. Scores were reported as mean values at 24 hours post-surgery and 48 hours post-surgery.
Interventions
- DRUG Epinephrine
- DRUG Ropivacaine
- DRUG Morphine
- DRUG 0.9% sodium chloride solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2016-10 |
| Est. Completion | 2018-09-21 |
| Phase | Phase 4 |
What the finished NCT02967172 record still lists
NCT02967172 is an interventional study that assigns participants to a tested intervention. The registered 100 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 (81% lower).
The record links to 0 conditions, and to 4 interventions - of which Epinephrine is the first listed.
NCT02967172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02967172 about?
NCT02967172 is a clinical study titled "Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures". The purpose of this study is to determine the efficacy and safety of a peri-articular multimodal injection for post-operative pain control following operative management of closed, rotational ankle fractures. Enrolled subjects will be randomized to either receive or not receive intra-operative injec...
What is the current status of trial NCT02967172?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2016-10. Estimated completion is 2018-09-21.
What interventions are being tested in trial NCT02967172?
The interventions under investigation include: Epinephrine (DRUG), Ropivacaine (DRUG), Morphine (DRUG), 0.9% sodium chloride solution (DRUG).
Who is sponsoring clinical trial NCT02967172?
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 NCT02967172's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 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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