Study of A Long Lasting Local Anesthestic for Hand, Wrist or Finger Surgery

Brief Summary

Official Title: “Exparel (Bupivacaine Liposome Injectable Suspension) for Distal Upper Extremity Blocks in Orthopedic Surgery”

The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: February 2016

Interventions Used in this Clinical Trial

  • Drug: Exparel Forearm block
    • 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
  • Drug: Bupivacaine supraclavicular block
    • 20-30mL 0.5% bupivacaine

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Exparel forearm block
    • Under ultrasound guidance, 3-5 mL Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
  • Active Comparator: Bupivacaine supraclavicular block
    • Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.

Outcome Measures for this Clinical Trial

Primary Measures

  • Onset of Sensorimotor block
    • Time Frame: 30 minutes
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • patients 18 years or older having hand, wrist, or finger surgery
  • ability to understand and provide informed consent
  • American Society of Anesthesiologists status I-III
  • presence of a responsible adult caregiver for 48-72 hours after surgery

Exclusion Criteria

  • patient refusal or inability to provide informed consent
  • true allergy, not sensitivity to local anesthetics, midazolam, fentanyl, hydromorphone, propofol
  • pregnancy
  • hepatic or renal failure
  • evidence of infection at or near the proposed needle insertion site
  • any sensorimotor deficit of the upper extremity
  • BMI greater than or equal to 35
  • uncontrolled or severe pulmonary disease
  • anticoagulant use (not aspirin or non-steroidal anti-inflammatories)
  • chronic pain patients

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • Jose Soberon, MD
  • Collaborator
    • Pacira Pharmaceuticals, Inc
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jose Soberon, MD, Anesthesiologist – Ochsner Health System
  • Overall Official(s)
    • Jose Soberon, MD, Principal Investigator, Ochsner Clinic Foundation
  • Overall Contact(s)
    • Jose Soberon, MD, 504-842-3755, jsoberon@ochsner.org

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT02058303