DBRCT on the Effect of Grip Strength in Brachial Plexus vs Distal Forearm Nerve Blocks

Overview

This is a double-blind prospective randomized control trial. The primary hypothesis is that the preservation of motor function is superior in distal forearm blocks compared to supraclavicular block. The secondary outcomes include patient satisfaction, surgeon's satisfaction, rate of block success, onset and duration of block.

Full Title of Study: “A Double-blind Randomized Controlled Trial Between Ultrasound-guided Brachial Plexus and Distal Peripheral Nerve Blocks for Hand Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2013

Interventions

  • Procedure: Proximal Brachial Plexus vs Distal Forearm Block
    • Proximal Brachial plexus block: 15 mls saline injected in distal forearm nerve block and 15 mls of 1.5% Mepivacaine injected to the brachial plexus via the supraclavicular approach. Distal forearm block: 15 mls 1.5% Mepivacaine injected in distal forearm nerve block and 15 mls of saline injected to the brachial plexus via the supraclavicular approach

Arms, Groups and Cohorts

  • Active Comparator: Proximal Brachial Plexus block
    • 15 mls of 1.5% Mepivacaine injected in the supraclavicular approach and 15 mls of saline injected in the distal forarm nerve blocks
  • Active Comparator: Distal Forearm block
    • 15 mls 1.5% Mepivacaine injected in distal forearm nerve block and 15 mls of saline injected to the brachial plexus via the supraclavicular approach

Clinical Trial Outcome Measures

Primary Measures

  • Grip Strength
    • Time Frame: 6 months
    • Maximal Grip Strength x3 using dynanometer

Secondary Measures

  • Patient Satisfaction
    • Time Frame: 6 months
    • Patient satisfaction on a linear numerical scale

Participating in This Clinical Trial

Inclusion Criteria

1. American Society of Anesthesiologists physical status I to III 2. Aged 18 and above 3. Able to provide own consent 4. Elective ambulatory surgery in the hand with an expected surgical time of less than 15 minutes that is normally performed with a peripheral nerve block covering the median and ulnar nerve distributions and intravenous sedation without general anesthesia Exclusion criteria:

1) Surgery outside the median and ulnar nerve distribution in the hand 2) Bilateral surgery 3) body mass index of more than 45 kg/m2 (higher chance of failure) 4) neck or clavicle deformities 5) infection at the injection site 6) existing neurologic disease 7) insulin dependent diabetes 8) Diabetes with peripheral neuropathy or end organ damage 9) allergy to LA agents 10) coagulopathy 11) Past surgery on the same upper limb 12) Any other contraindication to supraclavicular block or forearm blocks 13) Contraindication to monitored anesthesia care with peripheral nerve block as the mode of anesthesia. -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of New Mexico
  • Collaborator
    • VA Palo Alto Health Care System
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nicholas Lam, Associate Professor – University of New Mexico
  • Overall Official(s)
    • Nicholas Lam, MD, Principal Investigator, UNM

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