What side effects are associated with this type of intervention?

Common treatments for Total Knee Arthroplasty (TKA) include corticosteroids like Dexamethasone and Methylprednisolone acetate, and local anesthetics like bupivacaine. Corticosteroids can cause side effects such as hyperglycemia, especially in patients with diabetes, increased risk of infection, and potential for delayed wound healing. Bupivacaine, a local anesthetic, may cause side effects including local site reactions, systemic toxicity if absorbed in large amounts, and rare cases of nerve damage. Combining these agents aims to reduce inflammation and pain, but monitoring for these side effects is essential.

What prior FDA approvals exist?

The FDA has approved various treatments for managing pain and inflammation associated with Total Knee Arthroplasty (TKA). Corticosteroids like dexamethasone sodium phosphate and methylprednisolone acetate are commonly used for their potent anti-inflammatory and analgesic effects. Local anesthetics such as bupivacaine are also approved and widely used to provide nerve blocks that significantly reduce postoperative pain. These agents are often used in combination to enhance pain relief and improve recovery outcomes in TKA patients.

What other types of research exist?

Promising alternatives to B-DEX-MPA for TKA patients include: 1) Liposomal Bupivacaine (B-LB), which provides extended pain relief by slowly releasing bupivacaine over time. 2) Multimodal analgesia regimens incorporating gabapentin, ketamine, and dexamethasone, which have shown efficacy in reducing postoperative pain and opioid consumption. 3) Dexmedetomidine, an alpha-2 receptor agonist, which can enhance postoperative analgesia and reduce perioperative stress and inflammation. These alternatives offer different mechanisms of action and potential benefits for pain management in TKA patients.

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Local Anesthetic

Steroid-Enhanced Nerve Block vs Exparel for Knee Surgery Pain Management (Yale SEVEN Trial)

Phase 2

Recruiting

Led By Jinlei Li, MD PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

American Society of Anesthesiologists status I, II and III, elective, primary, bilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks and 3 months

Awards & highlights

Yale SEVEN Trial Summary

This trial evaluates a combo of drugs to see if it's more effective at controlling post-surgical knee pain than another combo.

Who is the study for?

This trial is for adults who are scheduled for elective, primary, bilateral knee replacement surgery and can receive spinal anesthesia with bupivacaine. They should not be pregnant, have coagulopathy or severe liver/renal issues, use opioids recently, or have certain conditions like uncontrolled diabetes.Check my eligibility

What is being tested?

The study compares two pain control methods after knee surgery: one combines dexamethasone and methylprednisolone with bupivacaine (B-DEX-MPA), while the other uses liposomal bupivacaine with plain bupivacaine (B-LB). It aims to see which provides better pain relief and recovery quality.See study design

What are the potential side effects?

Possible side effects include allergic reactions to the medications used in the nerve blocks, increased blood sugar levels from steroids like dexamethasone and methylprednisolone, potential infection at injection site, and general discomfort from nerve block procedure.

Yale SEVEN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for knee replacement surgery under spinal anesthesia.

Yale SEVEN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Postoperative Knee Pain Score

Postoperative opioid consumption

Secondary outcome measures

Average Postoperative Knee Pain Score

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10

Change in Quality of Recovery 40 questionnaire

+10 more

Yale SEVEN Trial Design

2Treatment groups

Experimental Treatment

Group I: B-LB in right knee and B-DEX-MPA in left kneeExperimental Treatment2 Interventions

Participants in this arm will receive B-LB in their right knee and B-DEX-MPA in their left knee. Nerve block with (B-LB): A medication mixture of 40 ml (20 ml LB and 20 ml 0.25% plain bupivacaine) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively. Nerve block with (B-DEX-MPA): A medication mixture of 40 ml (40 ml 0.25% plain bupivacaine, 10 mg DEX and 80 mg MPA) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.

Group II: B-LB in left knee and B-DEX-MPA in right kneeExperimental Treatment2 Interventions

Participants in this arm will receive B-LB in their left knee and B-DEX-MPA in their right knee. Nerve block with (B-LB): A medication mixture of 40 ml (20 ml LB and 20 ml 0.25% plain bupivacaine) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively. Nerve block with (B-DEX-MPA): A medication mixture of 40 ml (40 ml 0.25% plain bupivacaine, 10 mg DEX and 80 mg MPA) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Corticosteroids such as dexamethasone sodium phosphate and methylprednisolone acetate reduce inflammation and immune responses, thereby decreasing pain and swelling after Total Knee Arthroplasty (TKA). Local anesthetics like bupivacaine block nerve signals in the surgical area, providing direct pain relief by numbing the tissues. These treatments are essential for TKA patients as they help manage postoperative pain, reduce the need for narcotics, and improve overall recovery outcomes.

Postoperative intravenous dexamethasone administration: a preliminary investigation.Multiple Treatment Meta-Analysis of Intra-Articular Injection for Temporomandibular Osteoarthritis.Do Corticosteroids Attenuate the Peri-Operative Acute Phase Response After Total Knee Arthroplasty?