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CompletedNCT05906433InjectionsUpdated Sep 23, 2026

Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis

A Phase 1 interventional study of Kenalog with bupivacaine Injection in Knee Osteoarthritis, sponsored by Foundation for Orthopaedic Research and Education. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Foundation for Orthopaedic Research and Education · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jun 2025, 1 year 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • knee injection
  • Knee osteoarthritis
  • corticosteroid
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's enrollment of 75 is close to the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Foundation for Orthopaedic Research and Education is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
75 participants (actual)

Study 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.

    Drug: Kenalog with bupivacaine Injection

  • 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.

    Drug: Kenalog with bupivacaine Injection

  • 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.

    Drug: Kenalog with bupivacaine Injection

Interventions

  • DrugKenalog 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.

    Also known as: Knee Injection, Corticosteroid Injection, Kenalog, Bupivacaine

06

What researchers measure

Primary outcomes

  1. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Time frame: Prior to procedure (in office)

  2. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Time frame: Immediate post procedure (in office)

  3. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Time frame: 2 minutes post procedure (in office)

  4. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Time frame: Day 1 post procedure (phone interview)

  5. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Time frame: Day 14 post procedure (through EDC)

  6. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Time frame: Day 42 post procedure (in office)

  7. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Time frame: Day 84 post procedure (through EDC)

Secondary outcomes

  1. Assessment of Knee Pain

    Global Perceived Improvement

    Time frame: Immediate Post-op (in office)

  2. Assessment of Knee Pain

    Global Perceived Improvement

    Time frame: Day 1 post procedure (phone interview)

  3. Assessment of Knee Pain

    Global Perceived Improvement

    Time frame: Day 42 post procedure (in office)

  4. Assessment of Knee Pain

    Global Perceived Improvement

    Time frame: Day 84 post procedure (through EDC)

Other outcomes

  1. Medications

    Review of Medications

    Time frame: Prior to procedure (in office)

  2. Medications

    Review of Medications

    Time frame: Day 1 post procedure (phone interview)

  3. Medications

    Review of Medications

    Time frame: Day 14 post procedure (through EDC)

  4. Medications

    Review of Medications

    Time frame: Day 42 post procedure (in office)

  5. Medications

    Review of Medications

    Time frame: Day 84 post procedure (through EDC)

  6. Review of Adverse Events

    Any issues with procedure

    Time frame: Immediate post procedure (in office)

  7. Review of Adverse Events

    Any issues with procedure

    Time frame: Day 1 post procedure (phone interview)

  8. Review of Adverse Events

    Any issues with procedure

    Time frame: Day 42 post procedure (in office)

  9. Review of Adverse Events

    Any issues with procedure

    Time frame: Day 84 post procedure (through EDC)

07

Study locations

1 site
  • Florida Orthopaedic Institute
    Tampa, Florida 33637, United States
08

References and documents

Publications

  • 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. PubMed 29079170 ↗
  • 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. PubMed 33616067 ↗
  • 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. PubMed 20194319 ↗
  • 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. PubMed 12867587 ↗
  • 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. PubMed 17244900 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05906433
Lead sponsor
Foundation for Orthopaedic Research and Education
Collaborators
Florida Orthopaedic Institute
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
Jun 1, 2023
Primary completion
Jun 1, 2025
Completion
Dec 1, 2025
Last update
Sep 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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