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Exparel as a Nerve Block for Severe Hand Pain

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ClinicalTrials.gov Identifier: NCT02374320
Recruitment Status : Terminated (PI leaving institution)
First Posted : February 27, 2015
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Jose Soberon, MD, Ochsner Health System

Study Description
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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.

Condition or disease Intervention/treatment Phase
CREST Syndrome Peripheral Vascular Disease Raynaud Disease Scleroderma, Diffuse Drug: liposomal bupivacaine Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine
Study Start Date : November 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Exparel
20 mL liposomal bupivacaine injected once
 Drug: liposomal bupivacaine
injected as an axillary block


Outcome Measures
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Primary Outcome Measures :
  1. radial and ulnar arterial blood flow [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. pain measured by Visual analog scale. [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02374320


Locations
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United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Jose Soberon, MD
Investigators
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Principal Investigator: Jose Soberon, MD Ochsner Health System
More Information
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Responsible Party: Jose Soberon, MD, Anesthesiologist, Ochsner Health System
ClinicalTrials.gov Identifier: NCT02374320    
Other Study ID Numbers: 2014.155.C
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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CREST Syndrome
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Raynaud Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Cardiovascular Diseases
Connective Tissue Diseases
Skin Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Telangiectasis
Scleroderma, Limited
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents