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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Post Operative Pain; Foot Surgery; Ankle Surgery; Popliteal Nerve Block
• Intervention / Treatment: Drug: Exparel 266 MG Per 20 ML Injection; Drug: Bupivacaine Hcl 0.75% Inj; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants with foot and ankle procedures at Jefferson Surgery Center, Navy Yard
• Participants with foot and ankle orthopedic procedures requiring a preoperative nerve block
• Age 18 and older
• English speaking
• Ability to complete surveys by phone or in person
• Ability to provide informed consent

Exclusion Criteria:

• Revision foot and ankle cases
• Allergies to study medications
• Non-English speakers
• Known alcohol or narcotic abuse history
• Existing contract with a pain specialist due to underlying preoperative pain syndrome
• Preoperative opioid use within the 3 months prior to surgery
• Participants who are pregnant, plan to become pregnant, or are breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block; Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 10 mL of 0.75% bupivacaine	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
Active Comparator: Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block; Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 1 mL of 10 mg preservative free Dexamethasone + 10 cc's of 0.75% bupivacaine	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of pain medication used after surgery	Collected as tablets taken since all participants will be prescribed oxycodone	14 days
Pain level after surgery	Participants will be asked daily what their pain levels are using the Visual Analog (VAS) pain scale	14 days

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Estimated): June 17, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: DPED20242471

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes