Exparel as a Nerve Block for Severe Hand Pain

Peripheral Vascular Disease Clinical Trial

Official title:

Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02374320
• Other study ID #: 2014.155.C
• Status: Terminated
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• CREST Syndrome
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Raynaud Disease
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Vascular Diseases

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