Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study

NCT05279092 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2000031881000
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Postoperative Knee Pain Score

  Average postoperative knee pain scores for the first two postoperative days using Visual analogue scale (VAS) pain score. Score range from 0 (no pain) to 10 (worst pain possible).

  Day 1 and Day 2

• Postoperative opioid consumption

  In-hospital postoperative opioid consumption in oral milligram morphine equivalent (OME) will be monitored up to 48-hour between anesthesia end time and discharge time

  From anesthesia end time to discharge time, up to 48 hours

Secondary Outcomes (14)

• Average Postoperative Knee Pain Score

  Day 7

• Worst and best pain score

  Day 1, Day 2 and Day 7

• Change in functional pain using Brief Pain Inventory (BPI)

  baseline, 6 weeks and 3 months

• Change in neuropathic pain using PainDetect

  baseline, 6 weeks and 3 months

• Persistent opioid use using Yale Postoperative Recovery Scale

  Day 7, 6 weeks and 3 months

Study Arms (2)

Bupivacaine-Liposomal Bupivacaine (B-LB)

ACTIVE COMPARATOR

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.

Drug: Bupivacaine-Liposomal Bupivacaine

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

EXPERIMENTAL

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.

Drug: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate

Interventions

Bupivacaine-Liposomal Bupivacaine DRUG

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-Liposomal Bupivacaine (B-LB)

Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate DRUG

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Department of Anesthesiology Faculty Development Fund: collaborator

Study Sites (2)

Yale New Haven Hospital Saint Raphael Campus

New Haven, Connecticut, 06520, United States

RECRUITING

Yale New Haven Hospital York Street Campus

New Haven, Connecticut, 06520, United States

RECRUITING

Study Officials

• Jinlei Li, MD PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinlei Li, MD PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study medication mixture for nerve blocks for each study group will be prepared by an unblinded block nurse who will not be involved in block procedure or subsequent assessments. The patients, and the clinical team including the investigators who will perform the nerve blocks and assessors for subsequent patient follow ups will remain blinded to the group assignment throughout the study. Unblinding will occur after the 3-month follow-up is complete for the last enrolled patient.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 15, 2022
• Study Start: September 8, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)