Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study

Launched by YALE UNIVERSITY · Mar 3, 2022

Keywords

ClinConnect Summary

The Yale Steroid Enhanced Versus Exparel Nerveblock study is looking at two different methods to help manage pain after total knee replacement surgery. Researchers want to see whether a combination of two steroids (Dexamethasone and Methylprednisolone) along with a local pain medication (bupivacaine) can provide better pain relief than a special form of bupivacaine alone. The goal is to find out which approach helps patients recover more comfortably after their surgery.

To participate in this study, you would need to be between 65 and 74 years old and have a scheduled knee replacement surgery. You should be in generally good health, meaning you would typically be classified as a low to moderate risk for anesthesia. However, if you have certain conditions, like a severe allergy to the medications being studied, uncontrolled diabetes, or a history of substance abuse, you would not be eligible. If you join the study, you can expect to receive either treatment and will be asked to complete some follow-up questionnaires to help researchers understand your recovery and pain levels after surgery. This trial is currently recruiting participants.

Gender

ALL

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