NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study

RecruitingPhase 2

Sponsor: Yale University

Conditions: Total Knee Replacement, Knee Arthroplasty

Interventions: Bupivacaine-Liposomal Bupivacaine, Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate

Countries: United States

The objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing unilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB. This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (2)

New Haven, Connecticut, United States
New Haven, Connecticut, United States