Comparing two pain management methods after knee surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.

• Comparing two methods for pain control after knee replacement surgery

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

  Recruiting at 2 sites Phase 2 Yale University · New Haven, Connecticut and 1 other locations · NCT05736549

• Suzetrigine for pain relief after knee replacement

  This trial tests whether suzetrigine can reduce opioid use after a total knee replacement compared with placebo.

  Recruiting Phase 3 Hospital for Special Surgery, New York · New York, New York · NCT07864896

• Early home-based cycling after knee replacement

  This study tests whether starting a structured home cycling program soon after knee replacement is feasible and acceptable for patients already doing standard home rehab.

  Recruiting Central Jutland Regional Hospital · Silkeborg, Central Jutland · NCT07838012

• Femoral Component Alignment in Total Knee Replacement: Extramedullary vs Intramedullary Guidance

  This study tests whether an external (extramedullary) guide for placing the femoral component in knee replacement works as well as the traditional internal (intramedullary) guide.

  Recruiting I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Milan and 2 other locations · NCT07815080

• 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.

  Recruiting Jouf University · Sakakah · NCT07556003

• Dressing experiences and self-care after hip or knee replacement

  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.

  Recruiting Bournemouth University · Bournemouth, Dorset and 1 other locations · NCT07471243

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.