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

Hand Injuries Clinical Trial

Official title:

Exparel (Bupivacaine Liposome Injectable Suspension) for Distal Upper Extremity Blocks in Orthopedic Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02058303
• Other study ID #: 04262013
• Status: Terminated
• Phase: Phase 4
• First received: February 6, 2014
• Last updated: April 3, 2017
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2017
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Finger Injuries
• Hand Injuries
• Wounds and Injuries
• Wrist Injuries

Intervention

Drug:
• Exparel Forearm block
20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
• Bupivacaine supraclavicular block
20-30mL 0.5% bupivacaine

Locations

Country	Name	City	State
United States	Ochsner Clinic Foundation	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Jose Soberon, MD	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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