Study of A Long Lasting Local Anesthestic for Hand, Wrist or Finger Surgery

Jose Soberon, MD

Status and phase: Terminated; Phase 4

Conditions: Finger Injuries; Wrist Injuries; Hand Injuries

Treatments: Drug: Exparel Forearm block; Drug: Bupivacaine supraclavicular block

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02058303

04262013

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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37 participants in 2 patient groups

Exparel forearm block

Experimental group

Description:

Under ultrasound guidance, 3-5 milliliters (mL) Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.

Treatment:

Drug: Exparel Forearm block

Bupivacaine supraclavicular block

Active Comparator group

Description:

Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.

Treatment:

Drug: Bupivacaine supraclavicular block