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Liposomal Bupivacaine With Dexamethasone for Foot Surgery

NCT06465992 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-06-20

No results posted yet for this study

Summary

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.

Conditions

  • Foot Surgery
  • Ankle Surgery
  • Post Operative Pain
  • Popliteal Nerve Block

Interventions

DRUG

Exparel 266 MG Per 20 ML Injection

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

DRUG

Bupivacaine Hcl 0.75% Inj

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

DRUG

Dexamethasone

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

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-17
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06465992 on ClinicalTrials.gov