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

Primary Purpose

Hand Injuries, Wrist Injuries, Finger Injuries

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel Forearm block
Bupivacaine supraclavicular block
Sponsored by
Jose Soberon, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Injuries focused on measuring hand surgery, wrist surgery, finger surgery, anesthesia, regional anesthesia, postoperative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ochsner Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exparel forearm block

Bupivacaine supraclavicular block

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Onset of Sensorimotor block
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.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2014
Last Updated
April 3, 2017
Sponsor
Jose Soberon, MD
Collaborators
Pacira Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02058303
Brief Title
Study of A Long Lasting Local Anesthestic for Hand, Wrist or Finger Surgery
Official Title
Exparel (Bupivacaine Liposome Injectable Suspension) for Distal Upper Extremity Blocks in Orthopedic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
PI leaving instutition
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jose Soberon, MD
Collaborators
Pacira Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries, Wrist Injuries, Finger Injuries
Keywords
hand surgery, wrist surgery, finger surgery, anesthesia, regional anesthesia, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exparel forearm block
Arm Type
Experimental
Arm Description
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.
Arm Title
Bupivacaine supraclavicular block
Arm Type
Active Comparator
Arm Description
Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.
Intervention Type
Drug
Intervention Name(s)
Exparel Forearm block
Other Intervention Name(s)
bupivacaine liposome injectable suspension
Intervention Description
20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine supraclavicular block
Intervention Description
20-30mL 0.5% bupivacaine
Primary Outcome Measure Information:
Title
Onset of Sensorimotor block
Description
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.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Soberon, MD
Organizational Affiliation
Ochsner Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States

12. IPD Sharing Statement

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

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