Liposomal Bupivacaine With Dexamethasone for Foot Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-17

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Foot Surgery Ankle Surgery Post Operative Pain Popliteal Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Exparel 266 MG Per 20 ML Injection

Intervention Type DRUG

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

Bupivacaine Hcl 0.75% Inj

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Exparel 266 MG Per 20 ML Injection

Intervention Type DRUG

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

Bupivacaine Hcl 0.75% Inj

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

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

Interventions

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Exparel 266 MG Per 20 ML Injection

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

Intervention Type DRUG

Bupivacaine Hcl 0.75% Inj

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

Intervention Type DRUG

Dexamethasone

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes