Liposomal Bupivacaine With Dexamethasone for Foot Surgery

Rothman Institute Orthopaedics

Status and phase: Invitation-only; Phase 4

Conditions: Foot Surgery; Ankle Surgery; Popliteal Nerve Block; Post Operative Pain

Treatments: Drug: Exparel 266 MG Per 20 ML Injection; Drug: Dexamethasone; Drug: Bupivacaine Hcl 0.75% Inj

Study type: Interventional

Funder types: Other

Identifiers

NCT06465992

DPED20242471

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 2 patient groups

Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine Hcl 0.75% Inj

Drug: Exparel 266 MG Per 20 ML Injection

Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine Hcl 0.75% Inj

Drug: Dexamethasone

Drug: Exparel 266 MG Per 20 ML Injection