Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis (Injections)

Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis.

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).

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: Kenalog with bupivacaine Injection

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 Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Anne Meredith Baldy, CCRC; Phone Number: (813)978-9700; Email: ambaldy@foreonline.org
• Study Contact Backup: Name: Debbi Warren, RN; Phone Number: (813)978-9700; Email: dwarren@foreonline.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33637
      • Recruiting
      • Florida Orthopaedic Institute
      • Contact: Brian T Palumbo, MD; Phone Number: 813-978-9700; Email: bpalumbo@floridaortho.com
      • Contact: Thomas T Bernasek, MD; Phone Number: (813)978-9700; Email: Tbernasek@floridaortho.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kenalog with 0ml bupivacaine; 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.	Drug: Kenalog with bupivacaine Injection; 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.; Other Names: Bupivacaine; Kenalog; Knee Injection; Corticosteroid Injection
Experimental: Kenalog with 4ml bupivacaine; 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.	Drug: Kenalog with bupivacaine Injection; 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.; Other Names: Bupivacaine; Kenalog; Knee Injection; Corticosteroid Injection
Experimental: Kenalog with 0.25% bupivacaine; 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.	Drug: Kenalog with bupivacaine Injection; 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.; Other Names: Bupivacaine; Kenalog; Knee Injection; Corticosteroid Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injection for Knee Pain	Visual Analogue Scale (VAS)	Prior to procedure (in office)
Injection for Knee Pain	Visual Analogue Scale (VAS)	Immediate post procedure (in office)
Injection for Knee Pain	Visual Analogue Scale (VAS)	2 minutes post procedure (in office)
Injection for Knee Pain	Visual Analogue Scale (VAS)	Day 1 post procedure (phone interview)
Injection for Knee Pain	Visual Analogue Scale (VAS)	Day 14 post procedure (through EDC)
Injection for Knee Pain	Visual Analogue Scale (VAS)	Day 42 post procedure (in office)
Injection for Knee Pain	Visual Analogue Scale (VAS)	Day 84 post procedure (through EDC)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Knee Pain	Global Perceived Improvement	Immediate Post-op (in office)
Assessment of Knee Pain	Global Perceived Improvement	Day 1 post procedure (phone interview)
Assessment of Knee Pain	Global Perceived Improvement	Day 42 post procedure (in office)
Assessment of Knee Pain	Global Perceived Improvement	Day 84 post procedure (through EDC)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medications	Review of Medications	Prior to procedure (in office)
Medications	Review of Medications	Day 1 post procedure (phone interview)
Medications	Review of Medications	Day 14 post procedure (through EDC)
Medications	Review of Medications	Day 42 post procedure (in office)
Medications	Review of Medications	Day 84 post procedure (through EDC)
Review of Adverse Events	Any issues with procedure	Immediate post procedure (in office)
Review of Adverse Events	Any issues with procedure	Day 1 post procedure (phone interview)
Review of Adverse Events	Any issues with procedure	Day 42 post procedure (in office)
Review of Adverse Events	Any issues with procedure	Day 84 post procedure (through EDC)

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education
• Collaborators: Florida Orthopaedic Institute

Publications and helpful links

General Publications

• Bedard NA, Dowdle SB, Anthony CA, DeMik DE, McHugh MA, Bozic KJ, Callaghan JJ. Response to Letter to the Editor on "The AAHKS Clinical Research Award: What Are the Costs of Knee Osteoarthritis in the Year Prior to Total Knee Arthroplasty?". J Arthroplasty. 2018 Jan;33(1):307. doi: 10.1016/j.arth.2017.10.002. Epub 2017 Oct 10. No abstract available.
• Blankstein M, Lentine B, Nelms NJ. Common Practices in Intra-Articular Corticosteroid Injection for the Treatment of Knee Osteoarthritis: A Survey of the American Association of Hip and Knee Surgeons Membership. J Arthroplasty. 2021 Mar;36(3):845-850. doi: 10.1016/j.arth.2020.09.022. Epub 2020 Oct 8.
• Grishko V, Xu M, Wilson G, Pearsall AW 4th. Apoptosis and mitochondrial dysfunction in human chondrocytes following exposure to lidocaine, bupivacaine, and ropivacaine. J Bone Joint Surg Am. 2010 Mar;92(3):609-18. doi: 10.2106/JBJS.H.01847.
• Smith MD, Wetherall M, Darby T, Esterman A, Slavotinek J, Roberts-Thomson P, Coleman M, Ahern MJ. A randomized placebo-controlled trial of arthroscopic lavage versus lavage plus intra-articular corticosteroids in the management of symptomatic osteoarthritis of the knee. Rheumatology (Oxford). 2003 Dec;42(12):1477-85. doi: 10.1093/rheumatology/keg398. Epub 2003 Jul 16.
• Parker RD, Streem K, Schmitz L, Martineau PA; Marguerite Group. Efficacy of continuous intra-articular bupivacaine infusion for postoperative analgesia after anterior cruciate ligament reconstruction: a double-blinded, placebo-controlled, prospective, and randomized study. Am J Sports Med. 2007 Apr;35(4):531-6. doi: 10.1177/0363546506296313. Epub 2007 Jan 23.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Knee osteoarthritis; corticosteroid; knee injection
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: PI_ PAL_V3_ 8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No