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NCT Number: NCT03484247

Injection Optimization of Infraclavicular and Axillary Brachial Plexus Block

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.

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Key information

Conditions

Brachial Plexus Block

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diskapi TRH

Ankara, Turkey (Türkiye)

About this study

60 participants who underwent forearm or hand surgery with the axillary or infraclavicular brachial plexus block method and who have an American Society of Anesthesiologists physical status classification (ASA) score of I-II-III between the ages of 18-75 will be followed up. Number of needle attempts, block performance time, sensorial and motor block onset time, total anesthetic time, surgical duration, duration of sensory block formation, and duration of motor block formation will be evaluated with the information obtained from participants with axillary block or infraclavicular block. After surgery, participants satisfaction, visual analogue scales (VAS), sensory block ending times, motor block ending times and first analgesic requirement time will be assessed at postoperative 2. -8. -12. -24. hours by physical examination and questions. As a result of these evaluations, both groups will be compared statistically. (After the patients are informed in detail, the volunteer certificate will be obtained from the patients who agree to participate in the study.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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/)

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/)

Primary outcomes

  1. time to brachial plexus block performance

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

    performance time will hold with a stopwatch

Secondary outcomes

  1. number of needle attempt

    Time frame: during the procedure

    number of needle attempt will be count during the procedure

  2. time to brachial plexus block onset

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

    nerves will have sensorial and motor examination

Other outcomes

  1. patient satisfaction

    Time frame: 5 minutes after the operation

    patients will answer the question that 'how would you rate your satisfaction of procedure?'

    0:poor, 1:good, 2:excellent

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

Injection Optimization of Infraclavicular and Axillary Brachial Plexus Block: Comparison of Number of Attempts and Performance Time

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2018
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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