Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis.

PI_ PAL_V3_ 8

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).

2023-06-01

2024-06-01

2024-06-01

Recruiting

Early phase I

75

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "At screening/baseline, informed consent will be obtained, demographics and medical history will be collected, patient x-ray will be reviewed/KL grade confirmed, narcotic use in last 6 months will be screened using E-FORCSE (Florida Prescription Drug Monitoring Program) database, inclusion and exclusion criteria will be assessed, and patient will be randomized into one of the study groups. We will only include patients who are receiving unilateral knee injections. Further, patient's baseline information on VAS Pain and current medication (analgesic or NSAID) will be collected. VAS Pain will be also collected immediately after the intervention and 2 minutes after the intervention, in addition to global perceived improvement score and AEs.\n\nThe intervention in this study is intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic (0ml, 2ml or 4 ml of 0.25% bupivacaine).", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The PI standard of care is to offer patients who complain of knee pain a corticosteroids injection regardless of patient participation in a study. A consent will be obtained prior the injection by a trained/qualified team member. Subjects will be randomly allocated to groups by concealed allocation. Randomization sequence between three groups will be created using Excel and will be further stratified by sex within each block, to ensure even distribution. A set of numbered envelopes will be created, with each having one unique group assigned. A staff member will assign an envelope with group assignment upon consent and record envelope number ID. The ARNP will open an envelope, administer injection based on the group assigned. The ARNP will prepare the medication to maintain the double blinded aspect of the study. The ARNP is trained and experienced with injections and has giving injections for several years. She will not be involved in the evaluations of the patient pre/post injection.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

2023-06-15