Clinical trial
Exparel (Bupivacaine Liposome Injectable Suspension) for Distal Upper Extremity Blocks in Orthopedic Surgery
Name
04262013
Description
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.
Trial arms
Trial start
2014-02-01
Estimated PCD
2016-03-01
Trial end
2016-03-01
Status
Terminated
Phase
Early phase I
Treatment
Exparel Forearm block
20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
Arms:
Exparel forearm block
Other names:
bupivacaine liposome injectable suspension
Bupivacaine supraclavicular block
20-30mL 0.5% bupivacaine
Arms:
Bupivacaine supraclavicular block
Size
37
Primary endpoint
Onset of Sensorimotor Block
30 minutes
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}
Updated at
2024-05-21
1 organization
2 products
3 indications
Organization
Jose SoberonProduct
ExparelIndication
Hand InjuriesIndication
Wrist InjuriesIndication
Finger InjuriesProduct
Bupivacaine