Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2

Launched by YALE UNIVERSITY · Feb 17, 2023

Keywords

ClinConnect Summary

The Yale Steroid Enhanced Versus Exparel Nerveblock trial is studying two different pain management methods for patients undergoing bilateral total knee replacement surgery. The researchers want to compare the effectiveness of a combination of steroids (Dexamethasone and Methylprednisolone) with a standard pain medication (Bupivacaine) against a special formulation of Bupivacaine called Liposomal Bupivacaine. The goal is to see if the steroid combination provides better pain relief and improves recovery after surgery.

To participate in this trial, you should be between 65 and 74 years old and scheduled for elective knee replacement surgery. You should be generally healthy, with no severe medical issues that would prevent you from completing follow-up questionnaires. If eligible, you can expect to receive one of the two pain management treatments during your surgery and then report your experiences with pain and recovery afterward. This study is currently recruiting participants, and it aims to help improve pain management for future knee replacement surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • American Society of Anesthesiologists status I, II and III, elective, primary, bilateral 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