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

Phase 4

Terminated

• Conditions: Finger Injuries; Hand Injuries; Wrist Injuries
• Interventions: Drug: Bupivacaine supraclavicular block; Drug: Exparel Forearm block

• Registration Number: NCT02058303
• Lead Sponsor: Jose Soberon, MD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-10
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2023-04-28
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Results First Posted: 2024-05-21
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine supraclavicular block	Bupivacaine supraclavicular block	Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.
Exparel forearm block	Exparel Forearm block	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.

Primary Outcome Measures

Name	Time	Method
Onset of Sensorimotor Block	30 minutes	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.

Trial Locations

Locations (1)

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States