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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 is a Phase 4 study that has completed, run by University of Iowa. The registered enrollment target is 100 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02967172
The ClinicalTrials.gov registry entry for NCT02967172 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Epinephrine is the first listed.
NCT02967172 reports 0 study locations.
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.
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