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Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2

NCT05736549 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-05-14

No results posted yet for this study

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.

Conditions

  • Total Knee Replacement
  • Knee Arthroplasty

Interventions

DRUG

Bupivacaine-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.

DRUG

Bupivacaine -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.

Sponsors & Collaborators

  • Department of Anesthesiology Faculty Development Fund

    collaborator UNKNOWN

  • Yale University

    lead OTHER

Principal Investigators

  • Jinlei Li, MD PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2027-09-30
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05736549 on ClinicalTrials.gov