Comparing Two Injection Sites of Local Anesthetic for Hand Surgery

NCT02112006 | Completed

• 1 other identifier: Soberon Forearm
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• success of block

  number of participants that needed additional anesthesia

  up to 30 minutes after injection

Secondary Outcomes (1)

• pain scores

  up to 10 days after surgery

Other Outcomes (1)

• time to complete injection

  up to 30 minutes

Study Arms (2)

distal injection

EXPERIMENTAL

0.5% bupivacaine injected in the forearm

Procedure: 0.5% bupivacaine injected in the forearm

proximal injection

ACTIVE COMPARATOR

20-30ml of 0.5% bupivacaine

Procedure: 20-30ml of 0.5% bupivacaine.

Interventions

0.5% bupivacaine injected in the forearm PROCEDURE

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

distal injection

20-30ml of 0.5% bupivacaine. PROCEDURE

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

proximal injection

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jose Soberon, MD: lead

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

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

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jose Soberon, MD

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 11, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 22, 2016

Record last verified: 2015-10

Locations

US (1)