Back to resultsComparing Two Injection Sites of Local Anesthetic for Hand Surgery
Primary Purpose
Hand Injury, Wrist Injury, Finger Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
0.5% bupivacaine injected in the forearm
20-30ml of 0.5% bupivacaine.
Sponsored by
About this trial
This is an interventional treatment trial for Hand Injury focused on measuring hand surgery, wrist surgery, finger surgery, anesthesia, regional anesthesia, postoperative pain
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
Sites / Locations
- Ochsner Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
distal injection
proximal injection
Arm Description
0.5% bupivacaine injected in the forearm
20-30ml of 0.5% bupivacaine
Outcomes
Primary Outcome Measures
success of block
number of participants that needed additional anesthesia
Secondary Outcome Measures
pain scores
change in pain scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02112006
Brief Title
Comparing Two Injection Sites of Local Anesthetic for Hand Surgery
Official Title
A Comparison Of Distal Peripheral Nerve Blockade Versus Traditional Proximal Approaches For Hand Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jose Soberon, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injury, Wrist Injury, Finger Injury
Keywords
hand surgery, wrist surgery, finger surgery, anesthesia, regional anesthesia, postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
distal injection
Arm Type
Experimental
Arm Description
0.5% bupivacaine injected in the forearm
Arm Title
proximal injection
Arm Type
Active Comparator
Arm Description
20-30ml of 0.5% bupivacaine
Intervention Type
Procedure
Intervention Name(s)
0.5% bupivacaine injected in the forearm
Intervention Description
Median, Ulnar, and Radial nerve blocks performed in the forearm
Intervention Type
Procedure
Intervention Name(s)
20-30ml of 0.5% bupivacaine.
Intervention Description
supraclavicular, infraclavicular, or axillary nerve block using 20-30ml of 0.5% bupivacaine.
Primary Outcome Measure Information:
Title
success of block
Description
number of participants that needed additional anesthesia
Time Frame
up to 30 minutes after injection
Secondary Outcome Measure Information:
Title
pain scores
Description
change in pain scores
Time Frame
up to 10 days after surgery
Other Pre-specified Outcome Measures:
Title
time to complete injection
Description
difference between the end of injection time and the beginning
Time Frame
up to 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Soberon, MD
Organizational Affiliation
Ochsner Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparing Two Injection Sites of Local Anesthetic for Hand Surgery
We'll reach out to this number within 24 hrs