Amasya University Training and Research Hospital
Amasya, 05100, Turkey (Türkiye)
NCT Number: NCT07688889
The primary objective of this study is to determine whether patients' physical characteristics hold predictive value regarding the difficulty or ease of performing an interscalene block. By pre-identifying patients prone to difficult blocks, predicting procedure duration, and elucidating the factors influencing ultrasound image quality, this study aims to contribute to clinical practice and patient safety.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Amasya, 05100, Turkey (Türkiye)
Anthropometric measurements will be performed using a standard tape measure while the patient is in the supine position with the neck in a neutral and fully extended position. Neck circumference measured at the level of the cricoid cartilage, sternomental distance (the distance between the manubrium sterni and the mentum), and thyromental distance (the distance between the thyroid cartilage and the mentum) will be measured and recorded. Additionally, the ratio of neck circumference to thyromental distance will be calculated and added to the data.
Block Performance and Technical Data Observational data will be collected while the interscalene nerve block, which is routinely performed for upper extremity surgeries at our center, is administered under standard conditions. The moment the ultrasound probe touches the skin will be defined as the "block onset time," and the moment the block needle is withdrawn from the skin will be defined as the "block completion time." The difference between these two time points will be recorded as the "total performance time." If the number of needle insertions into the skin (number of punctures) is more than one, it will be specified. Under ultrasound guidance, brachial plexus depth (the distance between the skin and the C5 spinal nerve root, in cm) will be measured. The active ingredient and volume (mL) of the administered local anesthetic drug will be recorded in the data form.
Image Quality and Clinical Evaluation Ultrasound screen images obtained during the procedure will later be shown to 5 anesthesiology and reanimation specialists specified in the study plan, and they will be scored between 1 and 5 in terms of the clarity of anatomical structures.
At 5, 10, and 20 minutes following the block performance:
Sensory Block: evaluated in the C5 and C6 dermatome areas, Motor Block: evaluated via elbow flexion, Vital Signs: SpO_2 measured by peripheral pulse oximetry and heart rate (beats/minute) values will be monitored and recorded.
Success Criteria and Follow-up At the end of the 20th minute, block success will be evaluated by assessing whether the level of anesthesia required for surgery has been achieved. In cases where the block is insufficient, fails, or conversion to general anesthesia is required for any other reason, the reasons will be noted in detail.
Potential side effects and complications that may develop after the procedure (e.g., Horner's syndrome, hoarseness, dyspnea, vascular puncture, local anesthetic systemic toxicity [LAST]) will be monitored up to the 6th postoperative hour. In addition, the study will be completed by recording the total narcotic analgesic consumption in the first 24 hours, the patient satisfaction score at the 6th postoperative hour (scored from 0 to 10), and the Visual Analog Scale (VAS) score (scored from 0 to 10).
The obtained data will be analyzed using the SPSS software with appropriate statistical methods (correlation analysis, regression, etc.) to determine the relationship between anthropometric measurements, duration, and success.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 day
Evaluation of the success of ultrasound block application.
Time frame: 1 day
USG evaluation of block visibility
Amasya University
Other
The Effect of Anthropometric Measurements of Patients Undergoing Interscalene Block on Block Success, Performance Time , and Ultrasound Visibility Score.
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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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