Injection Optimization of Infraclavicular and Axillary Brachial Plexus Block

NCT03484247 | Completed

• 1 other identifier: sevtap 1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

In upper extremity surgery, brachial plexus block (BPB) is routinely applied successfully as general anesthesia (GA). However, BPB is less invasive technique than GA. Peripheral nerve blocks have some potential benefits, such as lower risk of nausea and vomiting, early ambulation, early discharge, and better control of postoperative pain. The BPB is applied to various areas such as axillary, supraclavicular, infraclavicular and interscalene areas under the guidance of ultrasound and nerve stimulator. Among these methods, BPB administration success rates are around 95-100%. The other condition is anesthetic time which is important for the turnover of operating room. Anesthetic time is the sum of the performance time and onset time. In addition performance time and number of needle attempts also associated with patient satisfaction. The primary aim of this study is to determine the number of attempts and the performance time with the onset time and anesthetic time. If the procedure is simple, the performance time may be shorter. Therefore, the investigators aim that comparison of two different procedures which are single injection infraclavicular brachial plexus block and multiple injection axillary brachial plexus block by ultrasound guidance. In addition, the investigators will examine the duration of anesthesia and surgery, the duration of sensory and motor block endings, patient comfort and pain scales in the postoperative period.

Conditions

Brachial Plexus Block

Keywords

infraclavicular block; axillary block

Outcome Measures

Primary Outcomes (1)

• time to brachial plexus block performance

  performance time will hold with a stopwatch

  from the first second of brachial plexus imaging with ultrasound until the needle remove from the skin will be assessed up to ten minutes

Secondary Outcomes (2)

• number of needle attempt

  during the procedure

• time to brachial plexus block onset

  after end of the procedure 5th, 10th, 15th, 20th, 25th, 30th minutes

Other Outcomes (1)

• patient satisfaction

  5 minutes after the operation

Study Arms (2)

Group Infraclavicular

ACTIVE COMPARATOR

Infraclavicular Brachial Plexus Block: The inferolateral of the subclavian artery will be targeted with a 85 mm peripheral nerve stimulator needle with ultrasound guidance. When the needle tip was seen near the posterior cord of brachial plexus local anesthetic will be administered with single injection after aspiration.

Other: Infraclavicular brachial plexus block

Group Axillary

ACTIVE COMPARATOR

Axillary Brachial Plexus Block: The procedure will be performed with a 50 mm peripheral nerve stimulator needle with ultrasound guidance. Local anesthetic will be administered with multiple injection (radial, ulnar, median and musculocutaneous nerves) after aspiration.

Other: axillary brachial plexus block

Interventions

Infraclavicular brachial plexus block OTHER

Infraclavicular block will be performed with ultrasound guidance and peripheric nerve stimulator. Local anesthetic will be administered after aspiration, via peripheric nerve needle according to mentioned technique ( https://www.nysora.com/)

Group Infraclavicular

axillary brachial plexus block OTHER

Axillary nerve block will be performed with ultrasound guidance and peripheric nerve stimulator. Local anesthetic will be administered after aspiration via peripheric nerve needle according to mentioned technique ( https://www.nysora.com/)

Group Axillary

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Axillary or infraclavicular brachial plexus block who underwent forearm or hand surgery
• ASA score I-II-III
• Body weight\> 45 kg or BMI \<40 kg / m2

You may not qualify if:

• Under 18 years old or over 75 years old
• Body weight \<45 kg or BMI\> 40 kg / m2
• ASA score above III
• Pregnant or lactating
• Coagulopathy or anticoagulant medication
• Allergies about using local anesthetic drugs
• Neurological deficit
• Renal insufficiency or liver failure

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

Diskapi TRH

Ankara, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 30, 2018
• Study Start: April 6, 2018
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 27, 2018

Record last verified: 2018-07

Locations

TU (1)