Dosage of Mepivacaine in Ultrasound Axillary Block
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01485653|
Recruitment Status : Completed
First Posted : December 5, 2011
Last Update Posted : December 8, 2011
The use of ultrasonography as an adjunct to regional anesthesia has significantly increased in recent years. Brachial plexus blockade by an axillary approach is amenable to the use of ultrasound guidance. Real time sonography of nerve structures ensures an optimal distribution of the block solution. When compared to other methods of nerve localization, sonography decreases: failure rate procedure time and the onset time for blockade. Furthermore, the use of ultrasound for peripheral nerve blockade demonstrates decreased procedure related complications such as nerve injury and unintentional vascular puncture.
Traditional axillary block techniques relying on surface anatomical landmarks require large volumes of local anesthetic, generally 40mL and greater. Utilizing the increased accuracy offered by ultrasound, some studies have shown that low volumes of local anesthetic can yield successful axillary plexus blockade. Therefore, the tradition of using large volumes of local anesthetic for axillary blocks, even without ultrasound, may not be warranted.
Although recent investigations support using a low volume of local anesthetic for brachial plexus blockade, there is a lack of outcome data from blinded randomised trials. The primary objective of this study was to evaluate 2 different volumes of local anesthetic for axillary blockade: 1) 20mL or 2) 30 mL. For the 2 different volumes used in this study, a 1.5% solution of mepivacaine was chosen due to its widespread clinical use in axillary blocks, which is secondary to: rapid onset of action, intermediate duration of effect, and relative low cost. The primary outcome was block success rate for outpatients undergoing distal upper limb surgery. Secondary objectives included comparing the 2 volumes with respect to: time required to perform the block, and onset of sensory and motor blockade.
|Condition or disease||Intervention/treatment|
|Nerve Block Neuromuscular Blockade Anesthesia||Drug: Mepivacaine|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effective Low Dosage of Mepivacaine in Ultrasound Guided Axillary Block in Patients Undergoing Distal Upper Extremity Surgery|
|Study Start Date :||April 2010|
|Primary Completion Date :||August 2010|
|Study Completion Date :||September 2010|
Experimental: Mepivacaine, Ultrasound Axillary Block
Group 1) 20mL 1.5% mepivacaine Group 2) 30mL 1.5% mepivacaine
Group 1) 20mL 1.5% mepivacaine, one dose Group 2) 30mL 1.5% mepivacaine, one dose
- Successful Block [ Time Frame: 30 minutes ]
Definitions of successful block Functional successful block: Sensory score of 0-1 in all 4 territories and motor score of 0-1 in 3 of 4 territories within 30 minutes of needle extraction.
Surgical successful block: no required intraoperative supplemental local anesthetic, light sedation <25mcg/kg/min propofol and absence of general endotracheal anesthesia.
- Time required until onset of sensory blockade. [ Time Frame: 30 minutes ]
Onset of Sensory blockade: Examined every 5 minutes following needle extraction using a blunt needle at 4 specific anatomic locations corresponding to radial, ulnar, median, and musculocutaneous distributions and compared with contralateral side using same stimulus.
Onset of Motor Blockade: Examined every 5 minutes following needle extraction. Wrist flexion: median nerve; wrist extension: radial nerve; abduction of 5th finger or straight finger adduction: ulnar nerve; elbow flexion (with forearm supinated): musculocutaneous nerve.
- Time taken until Onset of Motor Blockade [ Time Frame: 30 minutes ]Onset of Motor Blockade: Examined every 5 minutes following needle extraction. Wrist flexion: median nerve; wrist extension: radial nerve; abduction of 5th finger or straight finger adduction: ulnar nerve; elbow flexion (with forearm supinated): musculocutaneous nerve.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485653
|Principal Investigator:||Samuel Perov, M.D.||Wayne State University, Department of Anesthesiology|