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

Postoperative Mobility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927289
• Other study ID #: Lamproxvsdistal
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2013
• Last updated: August 21, 2013
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Mobility

Intervention

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

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	VA Palo Alto Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grip Strength	Maximal Grip Strength x3 using dynanometer	6 months	No
Secondary	Patient Satisfaction	Patient satisfaction on a linear numerical scale	6 months	No