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Liposomal Bupivacaine + Dexamethasone for Foot Surgery

Phase 4
Waitlist Available
Research Sponsored by Rothman Institute Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with foot and ankle procedures at Jefferson Surgery Center, Navy Yard
Participants with foot and ankle orthopedic procedures requiring a preoperative nerve block
Must not have
Existing contract with a pain specialist due to underlying preoperative pain syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights

Summary

"This trial aims to find the best way to provide pain relief for foot and ankle surgeries by comparing the use of liposomal bupivacaine alone versus liposomal bupivacaine combined with

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects may include reactions at the injection site, increased blood sugar levels due to dexamethasone, potential nerve damage from the block procedure, and typical risks associated with local anesthetics like weakness or numbness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had a foot or ankle surgery at Jefferson Surgery Center, Navy Yard.
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I am having foot or ankle surgery that needs a nerve block before surgery.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under the care of a pain specialist for pre-existing pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amount of pain medication used after surgery
Pain level after surgery

Trial Design

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

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Who is running the clinical trial?

Rothman Institute OrthopaedicsLead Sponsor
122 Previous Clinical Trials
21,578 Total Patients Enrolled
3 Trials studying Postoperative Pain
523 Patients Enrolled for Postoperative Pain
~84 spots leftby Jun 2025
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