Exparel as a Nerve Block for Severe Hand Pain
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ClinicalTrials.gov Identifier: NCT02374320 |
Recruitment Status :
Terminated
(PI leaving institution)
First Posted : February 27, 2015
Last Update Posted : April 4, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
CREST Syndrome Peripheral Vascular Disease Raynaud Disease Scleroderma, Diffuse | Drug: liposomal bupivacaine | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Chemical Sympathectomy Following Peripheral Nerve Block With Liposomal Bupivacaine |
Study Start Date : | November 2014 |
Actual Primary Completion Date : | March 2016 |
Actual Study Completion Date : | March 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Exparel
20 mL liposomal bupivacaine injected once
|
Drug: liposomal bupivacaine
injected as an axillary block |
- radial and ulnar arterial blood flow [ Time Frame: 1 hour ]
- pain measured by Visual analog scale. [ Time Frame: 1 month ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374320
United States, Louisiana | |
Ochsner Clinic Foundation | |
New Orleans, Louisiana, United States, 70121 |
Principal Investigator: | Jose Soberon, MD | Ochsner Health System |
Responsible Party: | Jose Soberon, MD, Anesthesiologist, Ochsner Health System |
ClinicalTrials.gov Identifier: | NCT02374320 |
Other Study ID Numbers: |
2014.155.C |
First Posted: | February 27, 2015 Key Record Dates |
Last Update Posted: | April 4, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
CREST Syndrome Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Raynaud Disease Scleroderma, Systemic Scleroderma, Diffuse Cardiovascular Diseases Connective Tissue Diseases Skin Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Telangiectasis Scleroderma, Limited Calcinosis Calcium Metabolism Disorders Metabolic Diseases Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |