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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06465992
Enrollment
126
Registered
2024-06-20
Start date
2024-06-17
Completion date
2025-06-30
Last updated
2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

20 mL Liposomal bupivacaine (Exparel, 266 mg) will be administered in the popliteal and saphenous block

DRUGBupivacaine Hcl 0.75% Inj

10 mL of 0.75% bupivacaine will be administered in popliteal and saphenous block

DRUGDexamethasone

1 mL of 10 mg Dexamethasone will be administered in the popliteal and saphenous block

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Amount of pain medication used after surgery14 daysCollected as tablets taken since all participants will be prescribed oxycodone
Pain level after surgery14 daysParticipants will be asked daily what their pain levels are using the Visual Analog (VAS) pain scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026