Exparel as a Nerve Block for Severe Hand Pain
Primary Purpose
CREST Syndrome, Peripheral Vascular Disease, Raynaud Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
liposomal bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for CREST Syndrome
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) status I-IV
Exclusion Criteria:
- True Allergy, not sensitivity to: local anesthetics, midazolam, fentanyl, propofol, ketamine
- Previous surgery or significant trauma involving the radial or ulnar arteries (previous history of angiography and intravascular catheter placement are permitted)
- Pregnancy
- Severe hepatic impairment
- Evidence of infection at or near the proposed needle insertion site
- Any sensorimotor deficit of the ipsilateral upper extremity, whether acute or chronic as determined by the PI and/or designee
Sites / Locations
- Ochsner Clinic Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exparel
Arm Description
20 mL liposomal bupivacaine injected once
Outcomes
Primary Outcome Measures
radial and ulnar arterial blood flow
Secondary Outcome Measures
pain measured by Visual analog scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02374320
Brief Title
Exparel as a Nerve Block for Severe Hand Pain
Official Title
Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
PI leaving institution
Study Start Date
November 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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate whether the use of the study drug (Exparel) is safe and effective for treating circulation problems and pain in the hand or fingers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CREST Syndrome, Peripheral Vascular Disease, Raynaud Disease, Scleroderma, Diffuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exparel
Arm Type
Experimental
Arm Description
20 mL liposomal bupivacaine injected once
Intervention Type
Drug
Intervention Name(s)
liposomal bupivacaine
Intervention Description
injected as an axillary block
Primary Outcome Measure Information:
Title
radial and ulnar arterial blood flow
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
pain measured by Visual analog scale.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) status I-IV
Exclusion Criteria:
True Allergy, not sensitivity to: local anesthetics, midazolam, fentanyl, propofol, ketamine
Previous surgery or significant trauma involving the radial or ulnar arteries (previous history of angiography and intravascular catheter placement are permitted)
Pregnancy
Severe hepatic impairment
Evidence of infection at or near the proposed needle insertion site
Any sensorimotor deficit of the ipsilateral upper extremity, whether acute or chronic as determined by the PI and/or designee
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
Plan to Share IPD
No
Learn more about this trial
Exparel as a Nerve Block for Severe Hand Pain
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