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Clinical Trials/NCT01927289
NCT01927289CompletedPhase 4

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

University of New Mexico1 site in 1 country14 target enrollmentStarted: March 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
14
Locations
1
Primary Endpoint
Grip Strength

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Proximal Brachial Plexus block

Active Comparator

15 mls of 1.5% Mepivacaine injected in the supraclavicular approach and 15 mls of saline injected in the distal forarm nerve blocks

Intervention: Proximal Brachial Plexus vs Distal Forearm Block (Procedure)

Distal Forearm block

Active Comparator

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

Intervention: Proximal Brachial Plexus vs Distal Forearm Block (Procedure)

Outcomes

Primary Outcomes

Grip Strength

Time Frame: 6 months

Maximal Grip Strength x3 using dynanometer

Secondary Outcomes

  • Patient Satisfaction(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nicholas Lam

Associate Professor

University of New Mexico

Study Sites (1)

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