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Enhanced Nerve Block for Total Knee Arthroplasty Pain Management (Yale SEVEN Trial)
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.
Yale SEVEN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowYale SEVEN Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Yale SEVEN Trial Design
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Who is running the clinical trial?
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- I am having a knee replacement for reasons other than wear and tear arthritis.I have severe nerve pain or damage.I have a blood clotting disorder.I have a weakened immune system, such as HIV or long-term steroid use.I am allergic or cannot use certain pain relievers and anesthetics.My kidney function is severely impaired.I am scheduled for knee surgery with spinal anesthesia.I have diabetes that requires insulin or is not well-controlled.I weigh less than 60 kg.I have not used opioids or regularly used marijuana in the month before my surgery.I have stomach or intestinal issues like ulcers or diverticulitis.I do not have an infection at the nerve block site or in my body.I am scheduled for knee surgery with spinal anesthesia.
- Group 1: Bupivacaine-Liposomal Bupivacaine (B-LB)
- Group 2: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (B-DEX-MPA)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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