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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Mobility
• Intervention / Treatment: Procedure: Proximal Brachial Plexus vs Distal Forearm Block

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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; Other Names: Supracalvicular block; Wrist block
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	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; Other Names: Supracalvicular block; Wrist block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip Strength	Maximal Grip Strength x3 using dynanometer	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient satisfaction on a linear numerical scale	6 months

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: VA Palo Alto Health Care System
• Investigators: Principal Investigator: Nicholas Lam, MD, UNM

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: August 21, 2013
• First Posted (Estimate): August 22, 2013

Study Record Updates

• Last Update Posted (Estimate): August 22, 2013
• Last Update Submitted That Met QC Criteria: August 21, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Ultrasound; Satisfaction; Grip Strength; supraclavicular block; distal forearm block
• Other Study ID Numbers: Lamproxvsdistal