NCT06465992

Liposomal Bupivacaine With Dexamethasone for Foot Surgery

Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Prior to Foot and Ankle Procedures: A Prospective Randomized Controlled Trial

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. It will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. We will compare liposomal bupivacaine (Exparel) and liposomal bupivacaine (Exparel) combined with dexamethasone to determine if the addition of dexamethasone significantly decreases postoperative narcotic use and prolongs analgesic effects when administered in a popliteal and saphenous block prior to foot and ankle orthopedic procedures.

Conditions

• Foot Surgery
• Ankle Surgery
• Post Operative Pain
• Popliteal Nerve Block

Interventions

Type	Name	Description
DRUG	Exparel 266 MG Per 20 ML Injection	20 mL Liposomal bupivacaine (Exparel, 266 mg) will be administered in the popliteal and saphenous block
DRUG	Bupivacaine Hcl 0.75% Inj	10 mL of 0.75% bupivacaine will be administered in popliteal and saphenous block
DRUG	Dexamethasone	1 mL of 10 mg Dexamethasone will be administered in the popliteal and saphenous block

Timeline

• Start date: 2024-06-17
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2024-06-20
• Last updated: 2024-06-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study