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Clinical Trials/NCT02058303
NCT02058303
Terminated
Phase 4

Exparel (Bupivacaine Liposome Injectable Suspension) for Distal Upper Extremity Blocks in Orthopedic Surgery

Jose Soberon, MD1 site in 1 country37 target enrollmentFebruary 2014

Overview

Phase
Phase 4
Intervention
Exparel Forearm block
Conditions
Hand Injuries
Sponsor
Jose Soberon, MD
Enrollment
37
Locations
1
Primary Endpoint
Onset of Sensorimotor Block
Status
Terminated
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
March 2016
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jose Soberon, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Jose Soberon, MD

Anesthesiologist

Ochsner Health System

Eligibility Criteria

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

Arms & Interventions

Exparel forearm block

Under ultrasound guidance, 3-5 milliliters (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.

Intervention: Exparel Forearm block

Bupivacaine supraclavicular block

Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.

Intervention: Bupivacaine supraclavicular block

Outcomes

Primary Outcomes

Onset of Sensorimotor Block

Time Frame: 30 minutes

A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted.

Study Sites (1)

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