Peripheral Vascular Disease Clinical Trial
Official title:
Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine
Verified date | April 2024 |
Source | Ochsner Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Jose Soberon, MD |
United States,
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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