Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis

NCT05906433 | Recruiting Phase 1 FDA Drug

• 1 other identifier: PI_ PAL_V3_ 8
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Osteoarthritis

Keywords

knee injection; Knee osteoarthritis; corticosteroid

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Assessment of Knee Pain

  Immediate Post-op (in office)

• Assessment of Knee Pain

  Day 1 post procedure (phone interview)

• Assessment of Knee Pain

  Day 42 post procedure (in office)

• Assessment of Knee Pain

  Day 84 post procedure (through EDC)

Other Outcomes (9)

• Medications

  Prior to procedure (in office)

• Medications

  Day 1 post procedure (phone interview)

• Medications

  Day 14 post procedure (through EDC)

Study Arms (3)

Kenalog with 0ml bupivacaine

EXPERIMENTAL

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

Kenalog with 4ml bupivacaine

EXPERIMENTAL

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

Kenalog with 0.25% bupivacaine

EXPERIMENTAL

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

Interventions

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.

Also known as: Knee Injection, Corticosteroid Injection, Kenalog, Bupivacaine

Kenalog with 0.25% bupivacaine; Kenalog with 0ml bupivacaine; Kenalog with 4ml bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation for Orthopaedic Research and Education: lead
• Florida Orthopaedic Institute: collaborator

Study Sites (1)

Florida Orthopaedic Institute

Tampa, Florida, 33637, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 29079170 BACKGROUND

• 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.

  PMID: 33616067 BACKGROUND

• 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.

  PMID: 20194319 BACKGROUND

• 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.

  PMID: 12867587 BACKGROUND

• 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.

  PMID: 17244900 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Triamcinolone Acetonide; Bupivacaine; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Anne Meredith Baldy, CCRC

CONTACT

(813)978-9700; ambaldy@foreonline.org

Debbi Warren, RN

CONTACT

(813)978-9700; dwarren@foreonline.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. The 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).

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)