Exparel as a Nerve Block for Severe Hand Pain

Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine

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.

Study Overview

• Status: Terminated
• Conditions: Scleroderma, Diffuse; Peripheral Vascular Disease; Raynaud Disease; CREST Syndrome
• Intervention / Treatment: Drug: liposomal bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exparel; 20 mL liposomal bupivacaine injected once	Drug: liposomal bupivacaine; injected as an axillary block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
radial and ulnar arterial blood flow	1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
pain measured by Visual analog scale.	1 month

Collaborators and Investigators

• Sponsor: Jose Soberon, MD
• Investigators: Principal Investigator: Jose Soberon, MD, Ochsner Health System

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Metabolic Diseases; Skin Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Gastrointestinal Diseases; Connective Tissue Diseases; Atherosclerosis; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Calcium Metabolism Disorders; Calcinosis; Telangiectasis; Scleroderma, Limited; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Raynaud Disease; CREST Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2014.155.C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No