Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2

Phase

Condition

Knee Replacement

Knee Surgery

Treatment

Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate

Bupivacaine-Liposomal Bupivacaine

Clinical Study ID

NCT05736549

2000031881_a

Ages > 18
All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

Refusal of consent
Pregnancy
Conditions making the patient unable to fill out questionnaire online, through emailor over the phone including with cognitive dysfunction, psychiatric disorder, ornon-English speaking patients, or lack of internet access which would prevent postdischarge follow-up electronically
Coagulopathy
Allergy to or for any other reasons cannot use Acetaminophen, Celebrex, localanesthetic bupivacaine, DEX, MPA or LB
Patients on any amounts of opioids within one month of the surgery date, any substanceabuse such as regular marijuana user (more frequent than once per month)
Insulin dependent or uncontrolled diabetes defined as, day of surgery finger stickglucose >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 orrheumatoid arthritis, history of surgery in the ipsilateral knee joint, revision TKAor 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 intestinalanastomoses, and non-specific ulcerative colitis

Study Design

Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate

February 07, 2023

March 31, 2026

Study Description

This phase 2 clinical trial will 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 bilateral total knee arthroplasty (TKA).

The primary objective of this 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 total knee arthroplasty (TKA). The secondary objective of this study is to test the effects of perineural use of B-DEX-MPA vs B-LB on the quality of postoperative recovery as well as surgical outcome and neuropathic pain among patients undergoing bilateral TKA.