Maximal Distance for Successful Supraclavicular Block

NCT02383134 | Unknown

• 1 other identifier: TunisianMH
• Study Type: observational
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Regional Anesthesia; Ultrasound; Supraclavicular Block

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• •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

• 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

• The presence of other complications such as hematoma, infection, pneumothorax.

  up to 48 hours post operative.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing upper limb surgery surgery (hand, forearm, elbow)

You may qualify if:

• ASA physical status I-III
• years of age, inclusive
• surgery less than 3 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Tunisian Military Hospital: lead

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor, MD

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 9, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 13, 2015

Record last verified: 2015-03