Injection Optimization of Infraclavicular and Axillary Brachial Plexus Block

Brachial Plexus Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484247
• Other study ID #: sevtap 1
• Status: Completed
• Phase: N/A
• Start date: April 6, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: July 2018
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brachial Plexus Block

Intervention

Other:
• Infraclavicular brachial plexus block
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
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/)

Locations

Country	Name	City	State
Turkey	Diskapi TRH	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient satisfaction	patients will answer the question that 'how would you rate your satisfaction of procedure?'; 0:poor, 1:good, 2:excellent	5 minutes after the operation
Primary	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	number of needle attempt	number of needle attempt will be count during the procedure	during the procedure
Secondary	time to brachial plexus block onset	nerves will have sensorial and motor examination	after end of the procedure 5th, 10th, 15th, 20th, 25th, 30th minutes