Exparel as a Nerve Block for Severe Hand Pain

NCT ID: NCT02374320

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-03-31

Brief 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exparel

20 mL liposomal bupivacaine injected once

Group Type: EXPERIMENTAL

liposomal bupivacaine

Intervention Type: DRUG

injected as an axillary block

Interventions

liposomal bupivacaine

injected as an axillary block

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jose Soberon, MD

OTHER

Sponsor Role: lead

Responsible Party

Jose Soberon, MD

Anesthesiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jose Soberon, MD

Role: PRINCIPAL_INVESTIGATOR

Ochsner Health System

Locations

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

2014.155.C

Identifier Type: -

Identifier Source: org_study_id