Comparing two methods for pain control after knee replacement surgery
Official title: Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2
Run by Yale University · NCT05736549 · Data updated 2026-11-12
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 | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Status | Recruiting |
| Started | February 7, 2023 |
| Main results expected | September 2027 |
| Study ends | March 2028 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT05736549 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with conditions such as coagulopathy, uncontrolled diabetes, or those on opioids may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with similar approaches to pain management in surgical settings, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing two pain management methods after knee surgery
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Femoral Component Alignment in Total Knee Replacement: Extramedullary vs Intramedullary Guidance
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Physical therapy to improve gait and foot pressure after total knee replacement.
This program will see if a structured physical therapy rehabilitation program helps women who had a unilateral total knee replacement (ages 40–70) walk more normally and balance weight better on their feet.
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This observational study tests how patients manage dressings and wound care after hip or knee replacement within an ERAS pathway, to see how comfortable the dressings are and what education patients find helpful.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.