Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study

Last updated: May 13, 2025
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

2

Condition

Knee Surgery

Knee Replacement

Treatment

Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate

Bupivacaine-Liposomal Bupivacaine

Clinical Study ID

NCT05279092
2000031881
000
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • American Society of Anesthesiologists status I, II and III, elective, primary,unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.

Exclusion

Exclusion Criteria:

  • Refusal of consent

  • Pregnancy

  • Conditions making the patient unable to fill out questionnaire online, through emailor over the phone including with cognitive dysfunction, psychiatric disorder, ornon-English speaking patients, or lack of internet access which would prevent postdischarge follow-up electronically

  • Coagulopathy

  • Allergy to or for any other reasons cannot use Acetaminophen, Celebrex, localanesthetic bupivacaine, DEX, MPA or LB

  • Patients on any amounts of opioids within one month of the surgery date, anysubstance abuse such as regular marijuana user (more frequent than once per month)

  • Insulin dependent or uncontrolled diabetes defined as, day of surgery finger stickglucose >200mg/dl, or HbA1C > 8.0%

  • Peripheral Nerve Block site or systemic infection

  • Immune compromise (e.g., HIV, chronic glucocorticoid use)

  • Severe pre-existing neuropathy

  • TKA for indications other than osteoarthritis such as post-traumatic injury orrheumatoid arthritis, history of surgery in the ipsilateral knee joint, revision TKAor bilateral TKA

  • Severe hepatic or renal dysfunction (GFR <50 ml/min)

  • Actual body weight <60 kg

  • Patients with active or latent peptic ulcers, diverticulitis, fresh intestinalanastomoses, and non-specific ulcerative colitis

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate
Phase: 2
Study Start date:
September 08, 2022
Estimated Completion Date:
March 31, 2028

Study Description

This phase 2, double blinded and randomized clinical trial will 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).

The primary 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 total knee arthroplasty (TKA). The secondary objective of this study is to test the effects of perineural use of B-DEX-MPA vs B-LB on the quality of postoperative recovery as well as surgical outcome and neuropathic pain among patients undergoing unilateral TKA.

This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.

This will be a single center study at Yale New Haven Hospital (YNHH) performed at two clinical sites: York St. Campus (York Street, New Haven) and St. Raphael Campus (Chapel Street, New Haven). 250 primary, elective and unilateral TKA patients will be enrolled, and equally randomized (1:1 ratio) to receive peripheral nerve blockade with B- LB or B-DEX-MPA.

Connect with a study center

  • Yale New Haven Hospital Saint Raphael Campus

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • Yale New Haven Hospital York Street Campus

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.