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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
Jose Soberon, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CREST Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 23, 2015
Last Updated
April 3, 2017
Sponsor
Jose Soberon, MD
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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

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Exparel as a Nerve Block for Severe Hand Pain

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