Comparing two pain management methods after knee surgery
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study
This study is testing two different pain management methods after knee surgery to see which one helps patients feel better and recover more effectively.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT05279092 on ClinicalTrials.gov |
What this trial studies
This phase 2, double-blinded, randomized clinical trial aims to evaluate the effectiveness of a combination of Dexamethasone sodium phosphate and Methylprednisolone acetate with plain bupivacaine against Liposomal Bupivacaine with plain bupivacaine for pain control in patients undergoing unilateral total knee arthroplasty. The study will enroll 250 patients at Yale New Haven Hospital, who will be randomly assigned to receive one of the two treatments. Additionally, the trial will assess the quality of postoperative recovery and surgical outcomes associated with each pain management approach.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective, primary, unilateral total knee arthroplasty with ASA 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 promise in using corticosteroids for pain management in surgical settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
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
- Email: jinlei.li@yale.edu
- Phone: 475-434-4038
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.