Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis

Phase 1

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Kenalog with bupivacaine Injection

• Registration Number: NCT05906433
• Lead Sponsor: Foundation for Orthopaedic Research and Education

Brief 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.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kenalog with 0ml bupivacaine	Kenalog with bupivacaine Injection	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.
Kenalog with 4ml bupivacaine	Kenalog with bupivacaine Injection	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.
Kenalog with 0.25% bupivacaine	Kenalog with bupivacaine Injection	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.

Primary Outcome Measures

Name	Time	Method
Injection for Knee Pain	Day 84 post procedure (through EDC)	Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Assessment of Knee Pain	Day 84 post procedure (through EDC)	Global Perceived Improvement

Trial Locations

Locations (1)

Florida Orthopaedic Institute; 🇺🇸 Tampa, Florida, United States