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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02058303
Recruitment Status : Terminated (PI leaving instutition)
First Posted : February 10, 2014
Last Update Posted : April 5, 2017
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
Jose Soberon, MD, Ochsner Health System

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.

Condition or disease Intervention/treatment Phase
Hand Injuries Wrist Injuries Finger Injuries Drug: Exparel Forearm block Drug: Bupivacaine supraclavicular block Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exparel (Bupivacaine Liposome Injectable Suspension) for Distal Upper Extremity Blocks in Orthopedic Surgery
Study Start Date : February 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02058303

United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Jose Soberon, MD
Pacira Pharmaceuticals, Inc
Principal Investigator: Jose Soberon, MD Ochsner Health System

Responsible Party: Jose Soberon, MD, Anesthesiologist, Ochsner Health System Identifier: NCT02058303     History of Changes
Other Study ID Numbers: 04262013
First Posted: February 10, 2014    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Jose Soberon, MD, Ochsner Health System:
hand surgery
wrist surgery
finger surgery
regional anesthesia
postoperative pain

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