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Completed

NCT Number: NCT06394960

Factors Predicting Blood Pressure Change With Interscalene Block

The primary aim of this study is to identify potential anthropometric features that predict the relationship between the Interscalene Block procedure and changes in blood pressure

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Key information

Conditions

Systolic Blood Pressure (20% or Greater Increase)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Konya City Hospital

Konya, Karatay, 42020, Turkey (Türkiye)

About this study

This prospective, randomized study will be carried out after obtaining the necessary ethical approval and informed consent from the patients. 110 adult volunteer patients who will undergo ISB for shoulder surgery anesthesia will be included in this study. Evaluation of the patients before ISB and anthropometric measurements before and after Interscalene Block will be performed by an anesthesiologist who is not involved in the study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA I-III, elective shoulder surgery will be performed

Exclusion criteria

  • Presence of advanced renal or hepatic insufficiency, serious respiratory or cardiovascular disease
  • History of chronic opioid or benzodiazepine use
  • Presence of allergy to the local anesthetic drugs used
  • ISB contraindication (such as neurological disorder in the extremity to be operated on, diaphragmatic paralysis in the opposite region of the side where the intervention is planned, infection in the intervention area).
  • Presence of high level anxiety
  • Patients with a Hospital Anxiety and Depression Scale (HADS) cut-off score of 10 for the anxiety subscale and 7 or higher for the depression subscale

Treatment and study plan

Primary outcomes

  1. Our primary aim in this study is to determine possible anthropometric features that will predict the relationship between interscalene block procedure and blood pressure change.

    Time frame: 60 minute

    Various anthropometric measurements (such as "neck diameter", "neck length" and "anterior scalene muscle thickness") may be effective in the spread of the local anesthetic agent during ISB, and these measurements may play a role as a factor in the blood pressure change associated with ISB.

Secondary outcomes

  1. The secondary aim of this study is to reveal the relationship between interscalene block and heart rate.

    Time frame: 60 minute

    Various anthropometric measurements (such as "neck diameter", "neck length" and "anterior scalene muscle thickness") may be effective in the spread of the local anesthetic agent during ISB, and these measurements may play a role as a factor in the heart rate change associated with ISB.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Factors Predicting Blood Pressure Change Associated With Interscalene Block, Prospective and Observational Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 1, 2024
Registry last updated
Jul 23, 2024

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.