Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05906433

Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis

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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Knee Injection, Corticosteroid Injection, Kenalog, Bupivacaine

Primary outcomes

  1. Injection for Knee Pain

    Time frame: Prior to procedure (in office)

    Visual Analogue Scale (VAS)

  2. Injection for Knee Pain

    Time frame: Immediate post procedure (in office)

    Visual Analogue Scale (VAS)

  3. Injection for Knee Pain

    Time frame: 2 minutes post procedure (in office)

    Visual Analogue Scale (VAS)

  4. Injection for Knee Pain

    Time frame: Day 1 post procedure (phone interview)

    Visual Analogue Scale (VAS)

  5. Injection for Knee Pain

    Time frame: Day 14 post procedure (through EDC)

    Visual Analogue Scale (VAS)

  6. Injection for Knee Pain

    Time frame: Day 42 post procedure (in office)

    Visual Analogue Scale (VAS)

  7. Injection for Knee Pain

    Time frame: Day 84 post procedure (through EDC)

    Visual Analogue Scale (VAS)

Secondary outcomes

  1. Assessment of Knee Pain

    Time frame: Immediate Post-op (in office)

    Global Perceived Improvement

  2. Assessment of Knee Pain

    Time frame: Day 1 post procedure (phone interview)

    Global Perceived Improvement

  3. Assessment of Knee Pain

    Time frame: Day 42 post procedure (in office)

    Global Perceived Improvement

  4. Assessment of Knee Pain

    Time frame: Day 84 post procedure (through EDC)

    Global Perceived Improvement

Other outcomes

  1. Medications

    Time frame: Prior to procedure (in office)

    Review of Medications

  2. Medications

    Time frame: Day 1 post procedure (phone interview)

    Review of Medications

  3. Medications

    Time frame: Day 14 post procedure (through EDC)

    Review of Medications

  4. Medications

    Time frame: Day 42 post procedure (in office)

    Review of Medications

  5. Medications

    Time frame: Day 84 post procedure (through EDC)

    Review of Medications

  6. Review of Adverse Events

    Time frame: Immediate post procedure (in office)

    Any issues with procedure

  7. Review of Adverse Events

    Time frame: Day 1 post procedure (phone interview)

    Any issues with procedure

  8. Review of Adverse Events

    Time frame: Day 42 post procedure (in office)

    Any issues with procedure

  9. Review of Adverse Events

    Time frame: Day 84 post procedure (through EDC)

    Any issues with procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Meredith Baldy, CCRC

CONTACT

[email protected]

(813)978-9700

Debbi Warren, RN

CONTACT

[email protected]

(813)978-9700

Sponsors and collaborators

Lead sponsor

Foundation for Orthopaedic Research and Education

Other

Collaborators

  • Florida Orthopaedic Institute

Registry information

Official study title

Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis.

Acronym: Injections

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2023
Registry last updated
Dec 9, 2024

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.

Published trials that share one or more normalized conditions with this study.