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NCT Number: NCT01927289

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

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.

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Key information

Conditions

Postoperative Mobility Behavior Personal Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists physical status I to III
  • Aged 18 and above
  • Able to provide own consent
  • 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

  • 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.

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Treatment and study plan

Proximal Brachial Plexus vs Distal Forearm Block

Procedure

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

Other names: Supracalvicular block, Wrist block

Primary outcomes

  1. Grip Strength

    Time frame: 6 months

    Maximal Grip Strength x3 using dynanometer

Secondary outcomes

  1. Patient Satisfaction

    Time frame: 6 months

    Patient satisfaction on a linear numerical scale

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • VA Palo Alto Health Care System

Registry information

Official study title

A Double-blind Randomized Controlled Trial Between Ultrasound-guided Brachial Plexus and Distal Peripheral Nerve Blocks for Hand Surgery

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 22, 2013
Registry last updated
Aug 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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