Comparing Two Injection Sites of Local Anesthetic for Hand Surgery

NCT ID: NCT02112006

Last Updated: 2016-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-03-31

Brief Summary

The purpose of this study is to compare two different injection sites for local anesthesia in patients having hand surgery. The hypothesis is that subjects receiving injections around the three nerves of the forearm will provide faster pain control and greater patient satisfaction than patients having one injection closer to the shoulder.

Conditions

Hand Injury; Wrist Injury; Finger Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

distal injection

0.5% bupivacaine injected in the forearm

Group Type: EXPERIMENTAL

0.5% bupivacaine injected in the forearm

Intervention Type: PROCEDURE

Median, Ulnar, and Radial nerve blocks performed in the forearm

proximal injection

20-30ml of 0.5% bupivacaine

Group Type: ACTIVE_COMPARATOR

20-30ml of 0.5% bupivacaine.

Intervention Type: PROCEDURE

supraclavicular, infraclavicular, or axillary nerve block using 20-30ml of 0.5% bupivacaine.

Interventions

0.5% bupivacaine injected in the forearm

Median, Ulnar, and Radial nerve blocks performed in the forearm

Intervention Type: PROCEDURE

20-30ml of 0.5% bupivacaine.

supraclavicular, infraclavicular, or axillary nerve block using 20-30ml of 0.5% bupivacaine.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients ≥ 18 years of age undergoing unilateral hand, wrist, or finger surgery
• Ability to understand and provide informed consent
• American Society of Anesthesiologists (ASA) status I-III

Exclusion Criteria

• Patient refusal or inability to provide informed consent
• True allergy, not sensitivity, to any of the following substances: Local Anesthetics, Midazolam, Fentanyl, Hydromorphone, Propofol
• Pregnancy
• Severe hepatic impairment
• Evidence of infection at or near the proposed needle insertion site
• Any sensorimotor deficit of the ipsilateral upper extremity, whether acute or chronic, as determined by the PI and designee
• Pulmonary disease of any kind that is uncontrolled or severe in nature
• Chronic pain patients, defined as someone diagnosed with chronic pain or a chronic pain condition, under the care of a chronic pain physician, or taking oral/intravenous narcotics consistently for 30 days prior to surgery

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

Sponsors

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

Soberon Forearm

Identifier Type: -

Identifier Source: org_study_id