Steroid cocktail may offer better pain control after knee replacement
NCT ID NCT05279092
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether a nerve block containing bupivacaine plus two steroids (dexamethasone and methylprednisolone) can provide better pain relief after total knee replacement than the standard combination of bupivacaine and liposomal bupivacaine (Exparel). About 250 adults undergoing knee replacement will receive one of the two nerve blocks. Researchers will compare pain scores and opioid use in the first two days after surgery, as well as recovery quality.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of bupivacaine, dexamethasone sodium phosphate, and methylprednisolone acetate
- What this could lead to
- If it works, this could offer a cheaper, more effective option for controlling pain after knee replacement surgery, reducing the need for opioids.
- What could go wrong
- This is a phase 2 trial, so results are still uncertain. The steroid combination may not provide better pain relief than the standard treatment, and there is a small risk of nerve damage or infection from the injection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Yale New Haven Hospital Saint Raphael Campus
RECRUITINGNew Haven, Connecticut, 06520, United States
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Yale New Haven Hospital York Street Campus
RECRUITINGNew Haven, Connecticut, 06520, United States
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