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Knee OsteoarthritisPhase 1InjectionsNCT05906433

Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis

A Phase 1 study testing Kenalog with bupivacaine Injection in people with Knee Osteoarthritis, run by Foundation for Orthopaedic Research and Education at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Kenalog with bupivacaine Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
1 Jun 2023to 1 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Florida Orthopaedic Institute

    Tampa, Florida, 33637

Other trials in United States

About this study

Official title: 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).

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.

Being tested
Kenalog with bupivacaine Injection
Keywords
knee injection, Knee osteoarthritis, corticosteroid
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kenalog with bupivacaine InjectionDrug

    Also called Knee Injection, Corticosteroid Injection, Kenalog, Bupivacaine

    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 groups in NCT05906433
Study groupRoleWhat they receive
Kenalog with 0ml bupivacaineExperimentalThe 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.
Receives: Drug: Kenalog with bupivacaine Injection
Kenalog with 4ml bupivacaineExperimentalThe 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.
Receives: Drug: Kenalog with bupivacaine Injection
Kenalog with 0.25% bupivacaineExperimentalThe 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.
Receives: Drug: Kenalog with bupivacaine Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Measured: Prior to procedure (in office)

  2. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Measured: Immediate post procedure (in office)

  3. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Measured: 2 minutes post procedure (in office)

  4. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Measured: Day 1 post procedure (phone interview)

  5. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Measured: Day 14 post procedure (through EDC)

  6. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Measured: Day 42 post procedure (in office)

  7. Injection for Knee Pain

    Visual Analogue Scale (VAS)

    Measured: Day 84 post procedure (through EDC)

Secondary outcomes (4)

  1. Assessment of Knee Pain

    Global Perceived Improvement

    Measured: Immediate Post-op (in office)

  2. Assessment of Knee Pain

    Global Perceived Improvement

    Measured: Day 1 post procedure (phone interview)

  3. Assessment of Knee Pain

    Global Perceived Improvement

    Measured: Day 42 post procedure (in office)

  4. Assessment of Knee Pain

    Global Perceived Improvement

    Measured: Day 84 post procedure (through EDC)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start1 Jun 2023
  3. Primary completion1 Jun 2025
  4. Study completion1 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05906433
Sponsor's protocol ID
PI_ PAL_V3_ 8
Acronym
Injections
Status last verified
Sep 2026
First submitted
5 Jun 2023
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Kenalog with bupivacaine Injection in people with Knee Osteoarthritis, run by Foundation for Orthopaedic Research and Education at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Injection for Knee Pain (time frame: Prior to procedure (in office)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05906433, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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