Florida Orthopaedic Institute
Tampa, Florida, 33637, United States
Location status: Recruiting
Location contact
Brian T Palumbo, MD
CONTACT
Thomas T Bernasek, MD
CONTACT
NCT Number: NCT05906433
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Tampa, Florida, 33637, United States
Location status: Recruiting
Brian T Palumbo, MD
CONTACT
Thomas T Bernasek, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Knee Injection, Corticosteroid Injection, Kenalog, Bupivacaine
Time frame: Prior to procedure (in office)
Visual Analogue Scale (VAS)
Time frame: Immediate post procedure (in office)
Visual Analogue Scale (VAS)
Time frame: 2 minutes post procedure (in office)
Visual Analogue Scale (VAS)
Time frame: Day 1 post procedure (phone interview)
Visual Analogue Scale (VAS)
Time frame: Day 14 post procedure (through EDC)
Visual Analogue Scale (VAS)
Time frame: Day 42 post procedure (in office)
Visual Analogue Scale (VAS)
Time frame: Day 84 post procedure (through EDC)
Visual Analogue Scale (VAS)
Time frame: Immediate Post-op (in office)
Global Perceived Improvement
Time frame: Day 1 post procedure (phone interview)
Global Perceived Improvement
Time frame: Day 42 post procedure (in office)
Global Perceived Improvement
Time frame: Day 84 post procedure (through EDC)
Global Perceived Improvement
Time frame: Prior to procedure (in office)
Review of Medications
Time frame: Day 1 post procedure (phone interview)
Review of Medications
Time frame: Day 14 post procedure (through EDC)
Review of Medications
Time frame: Day 42 post procedure (in office)
Review of Medications
Time frame: Day 84 post procedure (through EDC)
Review of Medications
Time frame: Immediate post procedure (in office)
Any issues with procedure
Time frame: Day 1 post procedure (phone interview)
Any issues with procedure
Time frame: Day 42 post procedure (in office)
Any issues with procedure
Time frame: Day 84 post procedure (through EDC)
Any issues with procedure
Contact information is provided by the study sponsor or research team.
Anne Meredith Baldy, CCRC
CONTACT
Debbi Warren, RN
CONTACT
Foundation for Orthopaedic Research and Education
Other
Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis.
Acronym: Injections
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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