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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Ochsner Health System
Sponsor:
Collaborator:
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
Jose Soberon, MD, Ochsner Health System
ClinicalTrials.gov Identifier:
NCT02058303
First received: February 6, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hand Injuries
Wrist Injuries
Finger Injuries
Drug: Exparel Forearm block
Drug: Bupivacaine supraclavicular block
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Ochsner Health System:

Primary Outcome Measures:
  • Onset of Sensorimotor block [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 90
Study Start Date: February 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Exparel Forearm block
20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
Other Name: bupivacaine liposome injectable suspension
Active Comparator: Bupivacaine supraclavicular block
Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.
Drug: Bupivacaine supraclavicular block
20-30mL 0.5% bupivacaine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058303

Contacts
Contact: Jose Soberon, MD 504-842-3755 jsoberon@ochsner.org

Locations
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Jose Soberon, MD    504-842-3755    jsoberon@ochsner.org   
Principal Investigator: Jose Soberon, MD         
Sponsors and Collaborators
Jose Soberon, MD
Pacira Pharmaceuticals, Inc
Investigators
Principal Investigator: Jose Soberon, MD Ochsner Clinic Foundation
  More Information

No publications provided

Responsible Party: Jose Soberon, MD, Anesthesiologist, Ochsner Health System
ClinicalTrials.gov Identifier: NCT02058303     History of Changes
Other Study ID Numbers: 04262013
Study First Received: February 6, 2014
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ochsner Health System:
hand surgery
wrist surgery
finger surgery
anesthesia
regional anesthesia
postoperative pain

Additional relevant MeSH terms:
Hand Injuries
Finger Injuries
Wrist Injuries
Wounds and Injuries
Arm Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014