RecruitingPhase 2NCT05736549

Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2


Sponsor

Yale University

Enrollment

66 participants

Start Date

Feb 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to investigate the efficacy of Dexamethasone sodium phosphate plus Methylprednisolone acetate in combination with plain bupivacaine ((B-DEX-MPA) compared with Liposomal Bupivacaine in combination with plain bupivacaine (B-LB) on post-surgical pain control among patients undergoing bilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB. This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is the second part of a trial comparing two pain management approaches used during and after total knee replacement (TKA) surgery. One approach uses a nerve block containing Exparel, a long-acting local anaesthetic. The other uses a nerve block with a steroid and standard local anaesthetic added to the mix. Both are injected around the knee nerves before surgery to control post-operative pain. The goal is to find which combination provides better pain relief, less opioid use, and faster recovery. Adults classified as low to moderate surgical risk (ASA classes I–III) who are having elective, primary, bilateral total knee replacement under spinal anaesthesia are eligible. Patients are excluded if they are pregnant, have cognitive or language barriers preventing follow-up questionnaires, have clotting disorders, are allergic to the study medications, have been on opioids in the month before surgery, have uncontrolled diabetes, active infections, immune compromise, severe nerve damage, or kidney/liver dysfunction. Participants receive their assigned nerve block before surgery and are followed up with online questionnaires about pain and function during recovery. This study matters because opioid-sparing pain control after joint replacement is a major priority in modern surgery — identifying the best combination could reduce both patient suffering and opioid-related risks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBupivacaine-Liposomal Bupivacaine

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.

DRUGBupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate

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.


Locations(2)

Yale New Haven Hospital Saint Raphael Campus

New Haven, Connecticut, United States

Yale New Haven Hospital York Street Campus

New Haven, Connecticut, United States

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NCT05736549


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