Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2

NCT05736549 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2000031881_a
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Total Knee Replacement; Knee Arthroplasty

Outcome Measures

Primary Outcomes (2)

• Change in Postoperative Knee Pain Score

  Average postoperative knee pain scores for the first two postoperative days using Visual analogue scale (VAS) pain score. Score range from 0 (no pain) to 10 (worst pain possible).

  Day 1 and Day 2

• Postoperative opioid consumption

  In-hospital postoperative opioid consumption in oral milligram morphine equivalent (OME) will be monitored up to 48-hour between anesthesia end time and discharge time

  From anesthesia end time to discharge time, up to 48 hours

Secondary Outcomes (13)

• Average Postoperative Knee Pain Score

  Day 7

• Worst and best pain score

  Day 1, Day 2 and Day 7

• Change in functional pain using Brief Pain Inventory (BPI)

  baseline, 6 weeks and 3 months

• Change in neuropathic pain using PainDetect

  baseline, 6 weeks and 3 months

• Persistent opioid use using Yale Postoperative Recovery Scale

  Day 7, 6 weeks and 3 months

Study Arms (2)

B-LB in left knee and B-DEX-MPA in right knee

EXPERIMENTAL

Participants in this arm will receive B-LB in their left knee and B-DEX-MPA in their right knee. Nerve block with (B-LB): 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. Nerve block with (B-DEX-MPA): 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.

Drug: Bupivacaine-Liposomal Bupivacaine; Drug: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate

B-LB in right knee and B-DEX-MPA in left knee

EXPERIMENTAL

Participants in this arm will receive B-LB in their right knee and B-DEX-MPA in their left knee. Nerve block with (B-LB): 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. Nerve block with (B-DEX-MPA): 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.

Drug: Bupivacaine-Liposomal Bupivacaine; Drug: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate

Interventions

Bupivacaine-Liposomal Bupivacaine DRUG

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.

Also known as: B-LB

B-LB in left knee and B-DEX-MPA in right knee; B-LB in right knee and B-DEX-MPA in left knee

Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate DRUG

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.

Also known as: B-DEX-MPA

B-LB in left knee and B-DEX-MPA in right knee; B-LB in right knee and B-DEX-MPA in left knee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists status I, II and III, elective, primary, bilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Department of Anesthesiology Faculty Development Fund: collaborator

Study Sites (2)

Yale New Haven Hospital Saint Raphael Campus

New Haven, Connecticut, 06520, United States

RECRUITING

Yale New Haven Hospital York Street Campus

New Haven, Connecticut, 06520, United States

RECRUITING

Study Officials

• Jinlei Li, MD PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinlei Li, MD PhD

CONTACT

475-434-4038; jinlei.li@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will conduct a randomized study based on a randomization table generated by a biostatistician on the day of the surgery by the same investigator who will also prepare the study medication and perform the nerve block procedure. Patients follow up will be performed by investigators blinded to group assignments.

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 21, 2023
• Study Start: February 7, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)