Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2
Yale University
66 participants
Feb 7, 2023
INTERVENTIONAL
Conditions
Summary
The objective of this study is to investigate the efficacy of Dexamethasone sodium phosphate plus Methylprednisolone acetate in combination with plain bupivacaine ((B-DEX-MPA) compared with Liposomal Bupivacaine in combination with plain bupivacaine (B-LB) on post-surgical pain control among patients undergoing bilateral 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
Inclusion Criteria1
- American Society of Anesthesiologists status I, II and III, elective, primary, bilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.
Exclusion Criteria14
- 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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Interventions
A medication mixture of 40 ml (20 ml LB and 20 ml 0.25% plain bupivacaine) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.
A medication mixture of 40 ml (40 ml 0.25% plain bupivacaine, 10 mg DEX and 80 mg MPA) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05736549