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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02058303
Other study ID # 04262013
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date February 2014
Est. completion date March 2016

Study information

Verified date May 2024
Source Ochsner Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.


Recruitment information / eligibility

Status Terminated
Enrollment 37
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients 18 years or older having hand, wrist, or finger surgery - ability to understand and provide informed consent - American Society of Anesthesiologists status I-III - presence of a responsible adult caregiver for 48-72 hours after surgery Exclusion Criteria: - patient refusal or inability to provide informed consent - true allergy, not sensitivity to local anesthetics, midazolam, fentanyl, hydromorphone, propofol - pregnancy - hepatic or renal failure - evidence of infection at or near the proposed needle insertion site - any sensorimotor deficit of the upper extremity - BMI greater than or equal to 35 - uncontrolled or severe pulmonary disease - anticoagulant use (not aspirin or non-steroidal anti-inflammatories) - chronic pain patients

Study Design


Intervention

Drug:
Exparel Forearm block
20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
Bupivacaine supraclavicular block
20-30mL 0.5% bupivacaine

Locations

Country Name City State
United States Ochsner Clinic Foundation New Orleans Louisiana

Sponsors (2)

Lead Sponsor Collaborator
Jose Soberon, MD Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Onset of Sensorimotor Block A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted. 30 minutes
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