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

NCT02058303 | Terminated Phase 4 Results DMC

• 1 other identifier: 04262013
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Keywords

hand surgery; wrist surgery; finger surgery; anesthesia; regional anesthesia; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Onset of Sensorimotor Block

  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.

  30 minutes

Study Arms (2)

Exparel forearm block

EXPERIMENTAL

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.

Drug: Exparel Forearm block

Bupivacaine supraclavicular block

ACTIVE COMPARATOR

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

Drug: Bupivacaine supraclavicular block

Interventions

Exparel Forearm block DRUG

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

Also known as: bupivacaine liposome injectable suspension

Exparel forearm block

Bupivacaine supraclavicular block DRUG

20-30mL 0.5% bupivacaine

Bupivacaine supraclavicular block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jose Soberon, MD: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Hand Injuries; Wrist Injuries; Finger Injuries; Pain, Postoperative

Condition Hierarchy (Ancestors)

Wounds and Injuries; Arm Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Ken Bode
• Organization: Ochsner Health System

ken.bode@ochsner.org

504.842.1936

Study Officials

• Jose Soberon, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 10, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Locations

US (1)