Liposomal Bupivacaine With Dexamethasone for Foot Surgery

Phase 4

• Conditions: Foot Surgery; Post Operative Pain; Ankle Surgery; Popliteal Nerve Block
• Interventions: Drug: Exparel 266 MG Per 20 ML Injection; Drug: Bupivacaine Hcl 0.75% Inj; Drug: Dexamethasone

• Registration Number: NCT06465992
• Lead Sponsor: Rothman Institute Orthopaedics

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study Start: 2024-06-17
• Study First Posted: 2024-06-20
• Last Update Posted: 2024-06-20
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block	Exparel 266 MG Per 20 ML Injection	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
Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block	Bupivacaine Hcl 0.75% Inj	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
Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block	Exparel 266 MG Per 20 ML Injection	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
Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block	Dexamethasone	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
Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block	Bupivacaine Hcl 0.75% Inj	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States