Maximal Distance for Successful Supraclavicular Block

Ultrasound Clinical Trial

Official title:

The Maximum Effective Needle-to-Nerve Distance for Anesthetic Ultrasound-Guided Supraclavicular Brachial Plexus Block

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02383134
• Other study ID #: TunisianMH
• Status: Not yet recruiting
• Phase: N/A
• First received: February 27, 2015
• Last updated: May 12, 2015
• Start date: May 2015
• Est. completion date: August 2015

Study information

• Verified date: March 2015
• Source: Tunisian Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Observational

Clinical Trial Summary

The achievement of peripheral nerve block requires several needle passes, with each of them being at risk of causing nerve injury either by direct trauma or intraneural injection even with the use of the ultrasound.

The ultrasound guided supraclavicular brachial plexus block is known to be at risk of pneumothorax and / or nerve injury.

This study is designed to determine the maximal effective distance away from the nerve for the injection to be effective.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• ASA physical status I-III

• 18-85 years of age, inclusive

• surgery less than 3 hours

Exclusion Criteria:

• contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)

• existing neurological deficit in the area to be blocked

• pregnancy

• history of neck surgery or radiotherapy

• inability to understand the informed consent and demands of the study

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Regional Anesthesia
• Supraclavicular Block
• Ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tunisian Military Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of the ultrasound guided supraclavicular block at 30 minutes after injection at a specific distance of the needle tip from the outer sheeth of the nerve		30 minutes	No
Secondary	•The onset time of sensory and motor block		the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin	No
Secondary	The proportion of inadequate and failed blocks.		the block success will be assessed for each patient every 5 min for 30 mins in the operating room beginning when the needle exits the skin	No
Secondary	The presence of other complications such as hematoma, infection, pneumothorax.		up to 48 hours post operative.	No