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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 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.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,255 Total Patients Enrolled
Department of Anesthesiology Faculty Development FundUNKNOWN
1 Previous Clinical Trials
250 Total Patients Enrolled
Jinlei Li, MD PhDPrincipal InvestigatorYale University
1 Previous Clinical Trials
250 Total Patients Enrolled

Media Library

Bupivacaine-Liposomal Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05736549 — Phase 2
Total Knee Arthroplasty Research Study Groups: B-LB in left knee and B-DEX-MPA in right knee, B-LB in right knee and B-DEX-MPA in left knee
Total Knee Arthroplasty Clinical Trial 2023: Bupivacaine-Liposomal Bupivacaine Highlights & Side Effects. Trial Name: NCT05736549 — Phase 2
Bupivacaine-Liposomal Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05736549 — Phase 2
Total Knee Arthroplasty Patient Testimony for trial: Trial Name: NCT05736549 — Phase 2

Frequently Asked Questions

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

Are researchers still recruiting participants for this experiment?

"As per the data on clinicaltrials.gov, this trial is actively seeking participants. It was posted initially on February 7th 2023 and has since been refreshed on February 17th of the same year."

Answered by AI

What kind of hazards may be associated with the administration of B-LB in the left knee and B-DEX-MPA in the right knee?

"Our experts at Power rated the safety of B-LB in left knee and B-DEX-MPA in right knee a 2 due to Phase 2 trial data, which implies there are some findings on security but none for effectiveness."

Answered by AI

How many individuals are participating in the research protocol?

"Affirmative. Clinical trial data on clinicaltrials.gov suggests that this research is currently seeking to enrol participants - 66 in total from two different sites, since its launch date of February 7th 2023 and last update on the 17th of the same month."

Answered by AI

What results is this trial expected to yield?

"The primary indicator of success in this study, to be assessed on Day 1 and Day 2, is the total Postoperative opioid consumption. Secondary objectives are Worst and best pain score (VAS ranging from 0-10), Change in functional pain (BPI scored as Mild Pain: 1-4, Moderate Pain 5-6 & Severe Pain 7–10) and Change in neuropathic pain (PainDetect nine item questionnaire with a range of -1 to +5)."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
What site did they apply to?
Yale New Haven Hospital York Street Campus
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I APPLIED BECAUSE MY RIGHT KNEE IS SO PAINFUL SOME TIMES I CANT WALK I NEED AS MUCH HELP AS I CAN I REALLY TRULLY NEED THE HELP FROM THE BOTTOM OF MY HEART THANKYOU.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2
2023. "Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05736549.
~27 spots leftby Mar 2025
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