Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis

Foundation for Orthopaedic Research and Education

Status and phase: Enrolling; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Drug: Kenalog with bupivacaine Injection

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05906433

PI_ PAL_V3_ 8

Details and patient eligibility

About

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).

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Kenalog with 0ml bupivacaine

Experimental group

Description:

The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0ml of bupivacaine. The patients will be randomized into this group.

Treatment:

Drug: Kenalog with bupivacaine Injection

Kenalog with 4ml bupivacaine

Experimental group

Description:

The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,4ml of bupivacaine. The patients will be randomized into this group.

Treatment:

Drug: Kenalog with bupivacaine Injection

Kenalog with 0.25% bupivacaine

Experimental group

Description:

The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0.25% of bupivacaine. The patients will be randomized into this group.

Treatment:

Drug: Kenalog with bupivacaine Injection