Recruiting
Phase 2

Steroid Enhanced vs. Exparel

Sponsor:

Yale University

Code:

NCT05279092

Conditions

Total Knee Replacement

Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine-Liposomal Bupivacaine

Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate

Study Details

Brief 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.

Conditions

Total Knee Replacement

Knee Arthroplasty

Study ID

NCT05279092

Start date

Sep 8, 2022

Status verified date

Jul, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Criteria:

  • Refusal of consent
  • Pregnancy
  • Conditions making the patient unable to fill out questionnaire online, through email or over the phone including with cognitive dysfunction, psychiatric disorder, or non-English speaking patients, or lack of internet access which would prevent post discharge follow-up electronically
  • Coagulopathy
  • Allergy to or for any other reasons cannot use Acetaminophen, Celebrex, local anesthetic bupivacaine, DEX, MPA or LB
  • Patients on any amounts of opioids within one month of the surgery date, any substance abuse such as regular marijuana user (more frequent than once per month)
  • Insulin dependent or uncontrolled diabetes defined as, day of surgery finger stick glucose >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 or rheumatoid arthritis, history of surgery in the ipsilateral knee joint, revision TKA or 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 intestinal anastomoses, and non-specific ulcerative colitis

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Bupivacaine-Liposomal Bupivacaine (B-LB)

Nerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with 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 Interspace between the popliteal artery and capsule of the posterior knee (iPACK) block.

experimental: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (B-DEX-MPA)

Nerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with 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.

Interventions

Bupivacaine-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

Bupivacaine -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.

Primary outcome measure

  • Postoperative Knee Pain Score [ Time Frame: Day 1 and Day 2 ]
  • Postoperative opioid consumption [ Time Frame: From anesthesia end time to discharge time, up to 48 hours ]

Central Contacts and Locations

Central contacts

Jinlei Li, MD PhD

475-434-4038jinlei.li@yale.edu

Locations

Yale New Haven Hospital Saint Raphael Campus

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Jinlei Li, MD PhD

475-434-4038jinlei.li@yale.edu

Yale New Haven Hospital York Street Campus

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Jinlei Li, MD PhD

475-434-4038jinlei.li@yale.edu

More Information

Sponsor

Yale University

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-23.