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Local Anesthetic

Enhanced Nerve Block for Total Knee Arthroplasty 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, unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.

Be older than 18 years old

Must not have

Severe pre-existing neuropathy

Coagulopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks and 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether two different types of pain medication will be more effective in managing post-surgical pain for patients undergoing a knee replacement.

Who is the study for?

This trial is for adults with good overall health status (ASA I-III) who are scheduled for a single knee replacement surgery and can receive spinal anesthesia. They must not have used opioids in the last month, have no allergies to study drugs, uncontrolled diabetes, severe liver or kidney issues, weigh at least 60 kg, and be able to complete online questionnaires.

What is being tested?

The study compares two pain control methods after knee surgery: one combines Dexamethasone and Methylprednisolone with bupivacaine; the other uses Liposomal Bupivacaine with bupivacaine. It aims to see which provides better pain relief and postoperative recovery.

What are the potential side effects?

Possible side effects include allergic reactions to the medications used, increased blood sugar levels from steroids like Dexamethasone and Methylprednisolone, potential nerve damage from injections near nerves, and general risks associated with local anesthetics.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for knee surgery with spinal anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe nerve pain or damage.

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I have a blood clotting disorder.

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I have a weakened immune system, such as HIV or long-term steroid use.

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I am allergic or cannot use certain pain relievers and anesthetics.

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My kidney function is severely impaired.

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I have diabetes that requires insulin or is not well-controlled.

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I weigh less than 60 kg.

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I have not used opioids or regularly used marijuana in the month before my surgery.

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I have stomach or intestinal issues like ulcers or diverticulitis.

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I do not have an infection at the nerve block site or in my body.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Knee

Opioids

Secondary study objectives

Interleukins

Average Postoperative Knee Pain Score

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

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (B-DEX-MPA)Experimental Treatment1 Intervention

Nerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with adductor canal block comprised of 30 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml); 20 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml) will be administered through an iPACK block.

Group II: Bupivacaine-Liposomal Bupivacaine (B-LB)Active Control1 Intervention

Nerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with adductor canal block comprised of 20 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 30 ml; 10 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 20 ml will be administered through an Interspace between the popliteal artery and capsule of the posterior knee (iPACK) block.

0 / 11Eligibility criteria met