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 Soberon
Product
Exparel
Indication
Hand Injuries
Indication
Wrist Injuries
Indication
Finger Injuries