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

NCT ID: NCT02058303

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-03-31

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.

Conditions

Hand Injuries; Wrist Injuries; Finger Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exparel Forearm block

Intervention Type: DRUG

20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.

Bupivacaine supraclavicular block

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine supraclavicular block

Intervention Type: DRUG

20-30mL 0.5% bupivacaine

Interventions

Exparel Forearm block

20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.

Intervention Type: DRUG

Bupivacaine supraclavicular block

20-30mL 0.5% bupivacaine

Intervention Type: DRUG

Other Intervention Names

bupivacaine liposome injectable suspension

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

Jose Soberon, MD

OTHER

Sponsor Role: lead

Responsible Party

Jose Soberon, MD

Anesthesiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jose Soberon, MD

Role: PRINCIPAL_INVESTIGATOR

Ochsner Health System

Locations

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

04262013

Identifier Type: -

Identifier Source: org_study_id