Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— Injections  

Official title:

Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906433
• Other study ID #: PI_ PAL_V3_ 8
• Status: Recruiting
• Phase: Phase 1
• Start date: June 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2023
• Source: Foundation for Orthopaedic Research and Education
• Contact: Sherri Leverett, CRC
• Phone: (813)910-3690
• Email: Sleverett[@]foreonline.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	Florida Orthopaedic Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Orthopaedic Research and Education	Florida Orthopaedic Institute

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medications	Review of Medications	Prior to procedure (in office)
Other	Medications	Review of Medications	Day 1 post procedure (phone interview)
Other	Medications	Review of Medications	Day 14 post procedure (through EDC)
Other	Medications	Review of Medications	Day 42 post procedure (in office)
Other	Medications	Review of Medications	Day 84 post procedure (through EDC)
Other	Review of Adverse Events	Any issues with procedure	Immediate post procedure (in office)
Other	Review of Adverse Events	Any issues with procedure	Day 1 post procedure (phone interview)
Other	Review of Adverse Events	Any issues with procedure	Day 42 post procedure (in office)
Other	Review of Adverse Events	Any issues with procedure	Day 84 post procedure (through EDC)
Primary	Injection for Knee Pain	Visual Analogue Scale (VAS)	Prior to procedure (in office)
Primary	Injection for Knee Pain	Visual Analogue Scale (VAS)	Immediate post procedure (in office)
Primary	Injection for Knee Pain	Visual Analogue Scale (VAS)	2 minutes post procedure (in office)
Primary	Injection for Knee Pain	Visual Analogue Scale (VAS)	Day 1 post procedure (phone interview)
Primary	Injection for Knee Pain	Visual Analogue Scale (VAS)	Day 14 post procedure (through EDC)
Primary	Injection for Knee Pain	Visual Analogue Scale (VAS)	Day 42 post procedure (in office)
Primary	Injection for Knee Pain	Visual Analogue Scale (VAS)	Day 84 post procedure (through EDC)
Secondary	Assessment of Knee Pain	Global Perceived Improvement	Immediate Post-op (in office)
Secondary	Assessment of Knee Pain	Global Perceived Improvement	Day 1 post procedure (phone interview)
Secondary	Assessment of Knee Pain	Global Perceived Improvement	Day 42 post procedure (in office)
Secondary	Assessment of Knee Pain	Global Perceived Improvement	Day 84 post procedure (through EDC)