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Exparel/Intervention group for Infections

Phase 3
Waitlist Available
Led By Thomas K Miller, MD
Research Sponsored by Carilion Clinic
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 self reported anytime from immediately post-op until 2 weeks post-operatively. likely 1-3 days
Awards & highlights
No Placebo-Only Group
Approved for 10 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved

Summary

This is a prospective, randomized study for adult patients presenting to the Carilion Clinic Institute of Orthopedics and Neurosurgery. Patients undergoing isolated ACL reconstruction will be eligible for inclusion. All patients will receive an adductor canal block (either with bupivacaine or Exparel. Patients will be given a pain diary for self-report of pill counts, pain scores, block duration, and pain control satisfaction). Pill counts and pain scores will also be taken by a team member at two and six-week post-operative visits. Primary outcomes include opioid requirements and pain scores.

Eligible Conditions
  • Infections
  • Anterior Cruciate Ligament Tear
  • Opioid Use Disorder
  • Postoperative Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~self reported anytime from immediately post-op until 2 weeks post-operatively. likely 1-3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and self reported anytime from immediately post-op until 2 weeks post-operatively. likely 1-3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total opioid consumption
Secondary study objectives
Block length
Pain control quantified by intervention-based pain scale
Pain control quantified by numerical rating scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exparel/Intervention groupExperimental Treatment2 Interventions
Will receive 10mL of standard 0.5% bupivacaine followed by 10mL of liposomal bupivacaine as adductor canal field block preoperatively
Group II: Standard of Care groupActive Control1 Intervention
Will receive 20mL of standard 0.5% bupivacaine as adductor canal field block preoperatively
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

Carilion ClinicLead Sponsor
79 Previous Clinical Trials
15,080 Total Patients Enrolled
3 Trials studying Infections
2,203 Patients Enrolled for Infections
Thomas K Miller, MDPrincipal InvestigatorCarilion Clinic
1 Previous Clinical Trials
17 Total Patients Enrolled
~13 spots leftby Nov 2025
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