Liposomal Bupivacaine + Dexamethasone for Foot Surgery

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Rothman Institute Orthopaedics

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this 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.

Eligibility Criteria

This trial is for individuals undergoing foot or ankle surgery who are interested in better pain management. The study is looking at patients receiving nerve blocks before their procedures to see if adding a medication, dexamethasone, can improve pain control.

Inclusion Criteria

I had a foot or ankle surgery at Jefferson Surgery Center, Navy Yard.

Ability to provide informed consent

I can complete surveys over the phone or in person.

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Exclusion Criteria

I am undergoing or have undergone a revision surgery on my foot or ankle.

Allergies to study medications

Non-English speakers

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Treatment Details

Interventions

Dexamethasone (Corticosteroid)

Trial OverviewThe study tests two approaches: one using liposomal bupivacaine (Exparel) alone and another combining Exparel with dexamethasone for nerve blocks. It aims to determine if the combination offers superior postoperative pain relief and reduces the need for narcotics after foot and ankle surgeries.

Participant Groups

2Treatment groups

Active Control

Group I: Study Group 1: Foot/Ankle Surgery with Exparel Nerve BlockActive Control2 Interventions

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

Group II: Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve BlockActive Control3 Interventions

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