Clinical trial NCT05906433: Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis
Official title: Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Knee Osteoarthritis
Keywords: knee injection
Knee osteoarthritis
corticosteroid
Lead sponsor: Foundation for Orthopaedic Research and Education
Sponsor class: OTHER
Collaborators: name: Florida Orthopaedic Institute
First posted: 2023-06-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Injection for Knee Pain
timeFrame: Prior to procedure (in office)
measure: Injection for Knee Pain
timeFrame: Immediate post procedure (in office)
measure: Injection for Knee Pain
timeFrame: 2 minutes post procedure (in office)
measure: Injection for Knee Pain
timeFrame: Day 1 post procedure (phone interview)
measure: Injection for Knee Pain
timeFrame: Day 14 post procedure (through EDC)
measure: Injection for Knee Pain
timeFrame: Day 42 post procedure (in office)
measure: Injection for Knee Pain
timeFrame: Day 84 post procedure (through EDC)
Secondary outcomes:
measure: Assessment of Knee Pain
timeFrame: Immediate Post-op (in office)
measure: Assessment of Knee Pain
timeFrame: Day 1 post procedure (phone interview)
measure: Assessment of Knee Pain
timeFrame: Day 42 post procedure (in office)
measure: Assessment of Knee Pain
timeFrame: Day 84 post procedure (through EDC)
Other outcomes:
measure: Medications
timeFrame: Prior to procedure (in office)
measure: Medications
timeFrame: Day 1 post procedure (phone interview)
measure: Medications
timeFrame: Day 14 post procedure (through EDC)
measure: Medications
timeFrame: Day 42 post procedure (in office)
measure: Medications
timeFrame: Day 84 post procedure (through EDC)
measure: Review of Adverse Events
timeFrame: Immediate post procedure (in office)
measure: Review of Adverse Events
timeFrame: Day 1 post procedure (phone interview)
measure: Review of Adverse Events
timeFrame: Day 42 post procedure (in office)
measure: Review of Adverse Events
timeFrame: Day 84 post procedure (through EDC)
Locations:
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
Study officials:
References:
citation: 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.
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.
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.
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.
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.