Hand Injury Clinical Trial
Official title:
A Comparison Of Distal Peripheral Nerve Blockade Versus Traditional Proximal Approaches For Hand Surgery
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Jose Soberon, MD |
United States,
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 |
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