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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.
American Society of Anesthesiologists status I, II and III, elective, primary, unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks and 3 months
Awards & highlights

Yale SEVEN Trial 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.Check my eligibility
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.See study design
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.

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 surgery with spinal anesthesia.
Select...
I am scheduled for knee surgery with spinal anesthesia.

Yale SEVEN Trial Timeline

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
Knee
Opioids
Secondary outcome measures
Interleukins
Average Postoperative Knee Pain Score
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10
+11 more

Yale SEVEN 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.

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Who is running the clinical trial?

Department of Anesthesiology Faculty Development FundUNKNOWN
1 Previous Clinical Trials
66 Total Patients Enrolled
Yale UniversityLead Sponsor
1,841 Previous Clinical Trials
2,734,277 Total Patients Enrolled
Jinlei Li, MD PhDPrincipal InvestigatorYale University
1 Previous Clinical Trials
66 Total Patients Enrolled

Media Library

Bupivacaine-Liposomal Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05279092 — Phase 2
Total Knee Arthroplasty Research Study Groups: Bupivacaine-Liposomal Bupivacaine (B-LB), Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (B-DEX-MPA)
Total Knee Arthroplasty Clinical Trial 2023: Bupivacaine-Liposomal Bupivacaine Highlights & Side Effects. Trial Name: NCT05279092 — Phase 2
Bupivacaine-Liposomal Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05279092 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate of participants enrolled in this trial?

"Affirmative, according to clinicaltrials.gov the trial is presently welcoming participants. This research began recruiting on September 8th 2022 and was recently revised on the 14th of that same month. In total, 250 individuals will be recruited from 2 sites."

Answered by AI

What are the anticipated outcomes of this research endeavor?

"This medical research initiative is intended to measure postoperative knee pain scores over a 48-hour time period. Secondary targets include changes in the PROMIS Global-10, WBC count, and VAS worst/best ratings for days 1, 2 and 7."

Answered by AI

Is participation in this experiment open at the present time?

"According to clinicaltrials.gov, this trial is currently recruiting participants since it was first launched on 9/8/2022 and the data has been recently refreshed on 9/14/2022."

Answered by AI

What potential hazards could arise from the injection of Bupivacaine-Dexamethasone Sodium Phosphate-Methylprednisolone Acetate?

"There is limited clinical data that supports the safety of Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate, so it earned a score of 2."

Answered by AI
~0 spots leftby Apr 2024