Clinical trial

Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine

Name
2014.155.C
Description
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.
Trial arms
Trial start
2014-11-01
Estimated PCD
2016-03-01
Trial end
2016-03-01
Status
Terminated
Phase
Early phase I
Treatment
liposomal bupivacaine
injected as an axillary block
Arms:
Exparel
Size
13
Primary endpoint
Radial and Ulnar Arterial Diameter
1 hour
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 13, 'type': 'ACTUAL'}}
Updated at
2024-05-21

1 organization

1 product

5 indications

Organization
Jose Soberon
Indication
Scleroderma
Indication
Diffuse