Pain Control After Total Knee Replacement

This study is looking at ways to manage pain after total knee replacement surgery (TKA). It compares two different medication mixtures given as nerve blocks. One mixture uses Bupivacaine-Liposomal Bupivacaine, and the other uses Bupivacaine-Dexamethasone Sodium Phosphate-Methylprednisolone Acetate. Researchers want to see if the second mixture (B-DEX-MPA) is better at controlling pain and improving recovery after surgery than the first mixture (B-LB). You may be able to join if you are an adult having total knee replacement surgery on both knees. The study will measure your pain levels and how much pain medication you use after surgery to see which treatment works best. The study plans to enroll 66 participants, but its current status is unclear.

Study design
This is an interventional study comparing two different medication mixtures for pain control. It plans to enroll 66 participants undergoing bilateral total knee replacement.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your pain levels and opioid use will be measured from the end of anesthesia until discharge, up to 48 hours after surgery.

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NCT05736549

Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2

Recruiting
PHASE2Ages 18+InterventionalSupportive care
Yale University
~66 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Bupivacaine-Liposomal BupivacaineBupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Postoperative Knee Pain Score
Measured over Day 1 and Day 2
+1 more outcome measured
Total Knee Replacement
Knee Arthroplasty
2 sites across 1 states
Connecticut2
  • Jinlei Li, MD PhD · PRINCIPAL_INVESTIGATOR · Yale University

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Change in Postoperative Knee Pain ScoreDay 1 and Day 2

    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).

  • Postoperative opioid consumptionFrom anesthesia end time to discharge time, up to 48 hours

    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