Dosage of Mepivacaine in Ultrasound Axillary Block

NCT01485653 | Completed

• 2 other identifiers: WSU irb# 0902006824need to get
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nerve Block; Neuromuscular Blockade; Anesthesia

Keywords

Brachial Plexus; Mepivacaine; Ultrasound; Axillary; Block

Outcome Measures

Primary Outcomes (1)

• Successful Block

  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.

  30 minutes

Secondary Outcomes (2)

• Time required until onset of sensory blockade.

  30 minutes

• Time taken until Onset of Motor Blockade

  30 minutes

Study Arms (1)

Mepivacaine, Ultrasound Axillary Block

EXPERIMENTAL

Group 1) 20mL 1.5% mepivacaine Group 2) 30mL 1.5% mepivacaine

Drug: Mepivacaine

Interventions

Mepivacaine DRUG

Group 1) 20mL 1.5% mepivacaine, one dose Group 2) 30mL 1.5% mepivacaine, one dose

Mepivacaine, Ultrasound Axillary Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Orthopedic forearm, wrist and hand surgery
• ASA I-III
• block procedure time less than 6 minutes
• pre-block sedation using less than 2 mcg fentanyl and less than .04 mg midazolam,
• patient consent to light pre-op sedation

You may not qualify if:

• Elbow/arm surgery longer than 2 hours
• ASA IV
• BMI greater than 35
• Pregnant patients
• history of CVA or scarring in the axillary to elbow area
• history of neurological impairment of either upper extremity
• Any allergies to local anesthetics coagulopathy,
• infection at the site of block
• patients requiring opioid therapy for chronic pain

Sponsors & Collaborators

• Wayne State University: lead

MeSH Terms

Conditions

Bites and Stings

Interventions

Mepivacaine

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Samuel Perov, M.D.

  Wayne State University, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Samuel Perov

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: December 5, 2011
• Study Start: April 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 8, 2011

Record last verified: 2011-12