RecruitingPhase 2NCT05279092

Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study

Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study

Sponsor

Yale University

Enrollment

250 participants

Start Date

Sep 8, 2022

Study Type

INTERVENTIONAL

Conditions

Total Knee Replacement Knee Arthroplasty

Summary

The objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing unilateral 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 compares two methods of nerve block for pain relief after total knee replacement surgery: a standard steroid-enhanced nerve block versus the longer-acting local anaesthetic Exparel (liposomal bupivacaine). The goal is to find which approach provides better and longer-lasting pain control. You may be eligible if: - You are 18 years or older - You are scheduled for an elective single-knee replacement (total knee arthroplasty) under spinal anesthesia - Your ASA status is I, II, or III You may NOT be eligible if: - You are pregnant - You have a coagulation disorder - You are allergic to acetaminophen, Celebrex, bupivacaine, dexamethasone, or other study medications - You used opioids within one month before surgery - You have uncontrolled diabetes (day-of-surgery blood sugar above 200 mg/dl or HbA1C above 8.0%) - You have severe kidney or liver dysfunction - You weigh less than 60 kg - You have active peptic ulcers, diverticulitis, or ulcerative colitis - You have peripheral nerve disease or significant neuropathy - You are having knee surgery for reasons other than osteoarthritis (e.g., trauma, rheumatoid arthritis) Talk to your doctor to see if this trial is right for you.

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

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 iPACK block

DRUGBupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate

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.