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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02374320
Other study ID # 2014.155.C
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date November 2014
Est. completion date March 2016

Study information

Verified date April 2024
Source Ochsner Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 13
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
liposomal bupivacaine
injected as an axillary block

Locations

Country Name City State
United States Ochsner Clinic Foundation New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Jose Soberon, MD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radial and Ulnar Arterial Diameter 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. 1 hour
Secondary Pain Measured by Numerical Rating Scale Numerical rating scale pain scores range from 0 (absence of pain) to 10 (worst pain imaginable) 1 month
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