Opioid-Sparing Analgesia After Total Knee Arthroplasty

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Department of Anesthesiology Faculty Development Fund
• Treatments: BB 1101; Bupivacaine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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 or other pain treatment or modulating agents such as Gabapentinoids, Ketamine, Dexmedetomidine, Clonidine, within one month of the surgery date, any substance abuse such as regular marijuana user (more frequent than once per month), above moderate alcohol user (female> 7 drinks/ week, male more than 14 drinks/ week)

• Insulin dependent or uncontrolled diabetes defined as, day of surgery finger stick glucose >150 mg/dl, or HbA1C > 7.0%

• 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 <50 kg.