Hand Injuries Clinical Trial
Official title:
Exparel (Bupivacaine Liposome Injectable Suspension) for Distal Upper Extremity Blocks in Orthopedic Surgery
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 |
Verified date | May 2024 |
Source | Ochsner Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Jose Soberon, MD | Pacira Pharmaceuticals, Inc |
United States,
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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