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Exparel as a Nerve Block for Severe Hand Pain

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.
 
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

Tracking Information
First Submitted Date  ICMJE February 23, 2015
First Posted Date  ICMJE February 27, 2015
Last Update Posted Date April 4, 2017
Study Start Date  ICMJE November 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2015)
radial and ulnar arterial blood flow [ Time Frame: 1 hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2015)
pain measured by Visual analog scale. [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exparel as a Nerve Block for Severe Hand Pain
Official Title  ICMJE Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • CREST Syndrome
  • Peripheral Vascular Disease
  • Raynaud Disease
  • Scleroderma, Diffuse
Intervention  ICMJE Drug: liposomal bupivacaine
injected as an axillary block
Study Arms  ICMJE Experimental: Exparel
20 mL liposomal bupivacaine injected once
Intervention: Drug: liposomal bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 21, 2016)
14
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2015)
27
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02374320
Other Study ID Numbers  ICMJE 2014.155.C
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jose Soberon, MD, Ochsner Health System
Study Sponsor  ICMJE Jose Soberon, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose Soberon, MD Ochsner Health System
PRS Account Ochsner Health System
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP