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

NCT01927289 | Completed Phase 4

• 1 other identifier: Lamproxvsdistal
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Mobility

Keywords

Ultrasound; supraclavicular block; distal forearm block; Grip Strength; Satisfaction

Outcome Measures

Primary Outcomes (1)

• Grip Strength

  Maximal Grip Strength x3 using dynanometer

  6 months

Secondary Outcomes (1)

• Patient Satisfaction

  6 months

Study Arms (2)

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

Procedure: Proximal Brachial Plexus vs Distal Forearm Block

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

Procedure: Proximal Brachial Plexus vs Distal Forearm Block

Interventions

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

Also known as: Supracalvicular block, Wrist block

Distal Forearm block; Proximal Brachial Plexus block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• University of New Mexico: lead
• VA Palo Alto Health Care System: collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Nicholas Lam, MD

  UNM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 22, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 22, 2013

Record last verified: 2013-08

Locations

US (1)