Exparel as a Nerve Block for Severe Hand Pain

Jose Soberon, MD

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Peripheral Vascular Disease; CREST Syndrome; Raynaud Disease; Scleroderma, Diffuse

Treatments: Drug: liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02374320

2014.155.C

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Exparel

Experimental group

Description:

20 mL liposomal bupivacaine injected once

Treatment:

Drug: liposomal bupivacaine