Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis

• Sponsor: Foundation for Orthopaedic Research and Education (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05906433
• Collaborator: Florida Orthopaedic Institute (Other)
• Enrollment: 75
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Kenalog with bupivacaine Injection	Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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).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 (Participant)
• Masking Description: The PI standard of care is to offer patients who complain of knee pain a corticosteroids injection regardless of patient participation in a study. A consent will be obtained prior the injection by a trained/qualified team member. Subjects will be randomly allocated to groups by concealed allocation. Randomization sequence between three groups will be created using Excel and will be further stratified by sex within each block, to ensure even distribution. A set of numbered envelopes will be created, with each having one unique group assigned. A staff member will assign an envelope with group assignment upon consent and record envelope number ID. The ARNP will open an envelope, administer injection based on the group assigned. The ARNP will prepare the medication to maintain the double blinded aspect of the study. The ARNP is trained and experienced with injections and has giving injections for several years. She will not be involved in the evaluations of the patient pre/post injection.
• Primary Purpose: Treatment
• Official Title: Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis.
• Actual Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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; 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
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; 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
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; 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

Outcome Measures

Primary Outcome Measures

1. Injection for Knee Pain [Prior to procedure (in office)]

   Visual Analogue Scale (VAS)

2. Injection for Knee Pain [Immediate post procedure (in office)]

   Visual Analogue Scale (VAS)

3. Injection for Knee Pain [2 minutes post procedure (in office)]

   Visual Analogue Scale (VAS)

4. Injection for Knee Pain [Day 1 post procedure (phone interview)]

   Visual Analogue Scale (VAS)

5. Injection for Knee Pain [Day 14 post procedure (through EDC)]

   Visual Analogue Scale (VAS)

6. Injection for Knee Pain [Day 42 post procedure (in office)]

   Visual Analogue Scale (VAS)

7. Injection for Knee Pain [Day 84 post procedure (through EDC)]

   Visual Analogue Scale (VAS)

Secondary Outcome Measures

1. Assessment of Knee Pain [Immediate Post-op (in office)]

   Global Perceived Improvement

2. Assessment of Knee Pain [Day 1 post procedure (phone interview)]

   Global Perceived Improvement

3. Assessment of Knee Pain [Day 42 post procedure (in office)]

   Global Perceived Improvement

4. Assessment of Knee Pain [Day 84 post procedure (through EDC)]

   Global Perceived Improvement

Other Outcome Measures

1. Medications [Prior to procedure (in office)]

   Review of Medications

2. Medications [Day 1 post procedure (phone interview)]

   Review of Medications

3. Medications [Day 14 post procedure (through EDC)]

   Review of Medications

4. Medications [Day 42 post procedure (in office)]

   Review of Medications

5. Medications [Day 84 post procedure (through EDC)]

   Review of Medications

6. Review of Adverse Events [Immediate post procedure (in office)]

   Any issues with procedure

7. Review of Adverse Events [Day 1 post procedure (phone interview)]

   Any issues with procedure

8. Review of Adverse Events [Day 42 post procedure (in office)]

   Any issues with procedure

9. Review of Adverse Events [Day 84 post procedure (through EDC)]

   Any issues with procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Orthopaedic Institute	Tampa	Florida	United States	33637

Sponsors and Collaborators

• Foundation for Orthopaedic Research and Education
• Florida Orthopaedic Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Foundation for Orthopaedic Research and Education
• ClinicalTrials.gov Identifier: NCT05906433
• Other Study ID Numbers: PI_ PAL_V3_ 8
• First Posted: Jun 15, 2023
• Last Update Posted: Jun 15, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Foundation for Orthopaedic Research and Education: knee injection; Knee osteoarthritis; corticosteroid
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Triamcinolone Acetonide; Triamcinolone; Triamcinolone hexacetonide; Bupivacaine; Triamcinolone diacetate

Study Results

No Results Posted as of Jun 15, 2023