Comparing Two Injection Sites of Local Anesthetic for Hand Surgery

Hand Injury Clinical Trial

Official title:

A Comparison Of Distal Peripheral Nerve Blockade Versus Traditional Proximal Approaches For Hand Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112006
• Other study ID #: Soberon Forearm
• Status: Completed
• Phase: N/A
• First received: April 8, 2014
• Last updated: March 21, 2016
• Start date: April 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2015
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Finger Injuries
• Finger Injury
• Hand Injuries
• Hand Injury
• Wrist Injuries
• Wrist Injury

Intervention

Procedure:
• 0.5% bupivacaine injected in the forearm
Median, Ulnar, and Radial nerve blocks performed in the forearm
• 20-30ml of 0.5% bupivacaine.
supraclavicular, infraclavicular, or axillary nerve block using 20-30ml of 0.5% bupivacaine.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Jose Soberon, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time to complete injection	difference between the end of injection time and the beginning	up to 30 minutes	No
Primary	success of block	number of participants that needed additional anesthesia	up to 30 minutes after injection	No
Secondary	pain scores	change in pain scores	up to 10 days after surgery	No