Exparel as a Nerve Block for Severe Hand Pain

NCT02374320 | Terminated Phase 2 Results DMC

• 1 other identifier: 2014.155.C
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain Measured by Numerical Rating Scale

  1 month

Study Arms (1)

Exparel

EXPERIMENTAL

20 mL liposomal bupivacaine injected once

Drug: liposomal bupivacaine

Interventions

liposomal bupivacaine DRUG

injected as an axillary block

Exparel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) status I-IV

You may not qualify if:

• 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

Sponsors & Collaborators

• Jose Soberon, MD: lead

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Scleroderma, Limited; Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Skin Diseases, Vascular; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Ken Bode
• Organization: Ochsner Health System

ken.bode@ochsner.org

504.842.1936

Study Officials

• Jose Soberon, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: February 27, 2015
• Study Start: November 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)