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Clinical Trials/NCT02374320
NCT02374320TerminatedPhase 2

Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine

Jose Soberon, MD1 site in 1 country13 target enrollmentStarted: November 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Sponsor
Enrollment
13
Locations
1
Primary Endpoint
Radial and Ulnar Arterial Diameter
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Exparel

Experimental

20 mL liposomal bupivacaine injected once

Intervention: liposomal bupivacaine (Drug)

Outcomes

Primary Outcomes

Radial and Ulnar Arterial Diameter

Time Frame: 1 hour

Radial and ulnar artery diameter was measured at baseline and 60 min after with a Doppler ultrasound system. A marker was used to indicate the site of initial transducer placement on the forearm to ensure that subsequent scans were performed at the same location.

Secondary Outcomes

  • Pain Measured by Numerical Rating Scale(1 month)

Investigators

Sponsor
Jose Soberon, MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Jose Soberon, MD

Anesthesiologist

Ochsner Health System

Study Sites (1)

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