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NCT05906433PHASE1RecruitingAccepts Healthy Volunteers

Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis

Foundation for Orthopaedic Research and Education

Start Date

6/1/2023

Completion Date

12/1/2025

Summary

To evaluate pain relief from corticosteroid injection with and without anesthetic as well as with variable volume of anesthetic. Pain relief will be measured using the VAS pain score at the time of the injection as well as several time points following the injection to capture pain relief longevity. The investigators intend to evaluate how well the patients tolerate corticosteroid mixtures without anesthetic as well as with different volumes of anesthetic. Primary measure will be the time from procedure when postoperative status is considered success (as measured by global perceived improvement score).

Detailed Description

Primary objective is to evaluate pain relief from corticosteroids, Kenalog without anesthetic as well as with different volumes of anesthetic. The investigators will measure the VAS pain score at the time of the injection as well as several time points following the injection. Additionally, the investigators will evaluate how long the injection provided pain relief for the patient. The secondary intend is to evaluate how well the patients tolerate Kenalog mixtures without anesthetic as well as with different volumes of anesthetic by using the VAS pain scale. The investigators hypothesize that patient with lower volume of injection will experience less pain during the procedure and that there will be no statistically significant difference in pain level between the study groups during the study period.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Patients must be 18 years of age and be able to consent for themselves. 2. OA grade Kellgren Lawrence Stage II or III. 3. Diagnosis of primary osteoarthritis. Exclusion Criteria: 1. Patients with other forms of arthritis such as inflammatory arthritis. 2. History of narcotic use for the past 6 months. 3. Kellgren Lawrence arthritis grade 1 or 4. 4. Pregnant women and prisoners.

Interventions

DRUG

Kenalog with bupivacaine Injection

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Conditions

Knee Osteoarthritis

Locations

Florida Orthopaedic Institute

Tampa, Florida 33637

United States