Comparing Two Injection Sites of Local Anesthetic for Hand Surgery

NCT02112006 — Not applicable, Completed, 60 participants, Jose Soberon, MD

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

Registry	NCT02112006
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: none, treatment
Enrollment	60 (Actual)
Sponsor	Jose Soberon, MD (Other)
Conditions	Hand Injury, Wrist Injury, Finger Injury
Interventions	0.5% bupivacaine injected in the forearm, 20-30ml of 0.5% bupivacaine. (Procedure)
Dates	start 2014-04-01, primary completion 2016-03-01, completion 2016-03-01, first posted 2014-04-11, last updated 2016-03-22
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
distal injection	Experimental	Procedure: 0.5% bupivacaine injected in the forearm	0.5% bupivacaine injected in the forearm
proximal injection	Active comparator	Procedure: 20-30ml of 0.5% bupivacaine.	20-30ml of 0.5% bupivacaine

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

+Outcome measures

Primary outcomes

success of block [up to 30 minutes after injection]: number of participants that needed additional anesthesia

Secondary outcomes

pain scores [up to 10 days after surgery]: change in pain scores

Other outcomes

time to complete injection [up to 30 minutes]: difference between the end of injection time and the beginning

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Ochsner Clinic Foundation	New Orleans, Louisiana	United States

+Investigators

Jose Soberon, MD, Principal investigator, Ochsner Health System