Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFoundation for Orthopaedic Research and Education

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients must be 18 years of age and be able to consent for themselves.

OA grade Kellgren Lawrence Stage II or III.

Diagnosis of primary osteoarthritis.

Disqualifiers

Patients with other forms of arthritis such as inflammatory arthritis.

History of narcotic use for the past 6 months.

Kellgren Lawrence arthritis grade 1 or 4.

Pregnant women and prisoners.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Kenalog with bupivacaine Injection

    Drug

    Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Kenalog with 0ml bupivacaineExperimental treatment 1 intervention
Group B: Kenalog with 4ml bupivacaineExperimental treatment 1 intervention
Group C: Kenalog with 0.25% bupivacaineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Injection for Knee Pain

Visual Analogue Scale (VAS)

Time frame
Prior to procedure (in office)
2

Injection for Knee Pain

Visual Analogue Scale (VAS)

Time frame
Immediate post procedure (in office)
3

Injection for Knee Pain

Visual Analogue Scale (VAS)

Time frame
2 minutes post procedure (in office)
4

Injection for Knee Pain

Visual Analogue Scale (VAS)

Time frame
Day 1 post procedure (phone interview)

Secondary outcomes

1

Assessment of Knee Pain

Global Perceived Improvement

Time frame
Immediate Post-op (in office)
2

Assessment of Knee Pain

Global Perceived Improvement

Time frame
Day 1 post procedure (phone interview)
3

Assessment of Knee Pain

Global Perceived Improvement

Time frame
Day 42 post procedure (in office)
4

Assessment of Knee Pain

Global Perceived Improvement

Time frame
Day 84 post procedure (through EDC)

Other outcomes

1

Medications

Review of Medications

Time frame
Prior to procedure (in office)
2

Medications

Review of Medications

Time frame
Day 1 post procedure (phone interview)
3

Medications

Review of Medications

Time frame
Day 14 post procedure (through EDC)
4

Medications

Review of Medications

Time frame
Day 42 post procedure (in office)

Sponsors and contacts

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Foundation for Orthopaedic Research and Education

Lead sponsor

Florida Orthopaedic Institute

Collaborator