Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis

Part of paid clinical trials in Tampa, Florida.

Sponsor
Foundation for Orthopaedic Research and Education
Study ID
NCT05906433
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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).

Key Dates

Start date
Jun 1, 2023
Status verified
Dec 2024
Primary completion
Jun 1, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Injection for Knee Pain [ Time Frame: Prior to procedure (in office) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida Orthopaedic InstituteTampaFlorida33637
Brian T Palumbo, MD
[email protected]
813-978-9700
Thomas T Bernasek, MD
[email protected]
(813)978-9700

Find similar trials in Tampa, FL

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Florida Orthopaedic Institute· Tampa, FL

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