Comparing two methods for pain control after knee replacement surgery

Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2

This study is testing two different pain control methods after knee replacement surgery to see which one helps patients feel better and recover faster.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yale University (other)
• Locations: 2 sites (New Haven, Connecticut and 1 other locations)
• Trial ID: NCT05736549 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of a combination of Dexamethasone sodium phosphate and Methylprednisolone acetate with plain bupivacaine against Liposomal Bupivacaine with plain bupivacaine for managing post-surgical pain in patients undergoing bilateral total knee arthroplasty. The study will evaluate pain control and the quality of postoperative recovery among participants. Conducted at Yale New Haven Hospital, it will enroll approximately 66 patients scheduled for elective knee replacement surgery. The trial will assess both analgesic efficacy and recovery outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients scheduled for elective bilateral total knee arthroplasty who are classified as American Society of Anesthesiologists status I, II, or III.

Not a fit: Patients with conditions such as coagulopathy, uncontrolled diabetes, or those on opioids may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management and recovery for patients undergoing knee replacement surgery.

How similar studies have performed: Previous studies have shown promising results with similar approaches to pain management in surgical settings, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* American Society of Anesthesiologists status I, II and III, elective, primary, bilateral 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

Where this trial is running

New Haven, Connecticut and 1 other locations

• Yale New Haven Hospital Saint Raphael Campus — New Haven, Connecticut, United States (RECRUITING)
• Yale New Haven Hospital York Street Campus — New Haven, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Jinlei Li, MD PhD — Yale University
• Study coordinator: Jinlei Li, MD PhD

Conditions: Total Knee Replacement, Knee Arthroplasty