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Regional Block Plus Exparel for Bunions

N/A
Waitlist Available
Led By Christopher Hyer, DPM
Research Sponsored by OhioHealth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)
Awards & highlights

Summary

Exparel is an FDA-approved local anesthetic (bupivacaine), in a long-release formulation. In this study the investigators plan to determine the ability of Exparel to control post-operative pain in common first metatarsophalangeal (MTP) joint procedures (bunion surgery, 1st MTP fusion, and cheilectomy).

Eligible Conditions
  • Bunions
  • Hallux Rigidus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid Use as Measured by Questionnaire
Total Opioid Use as Measured by Questionnaire
Secondary outcome measures
Pain Relief Measured by Defense and Veterans Pain Scale

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Regional Block Plus ExparelExperimental Treatment2 Interventions
Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.
Group II: Regional BlockActive Control1 Intervention
Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine
FDA approved
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

OhioHealthLead Sponsor
30 Previous Clinical Trials
5,515 Total Patients Enrolled
Christopher Hyer, DPMPrincipal InvestigatorOhioHealth
~0 spots leftby Sep 2025
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