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Clinical Trials/NCT06394960
NCT06394960
Completed
Not Applicable

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

Konya City Hospital1 site in 1 country110 target enrollmentMay 2, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Systolic Blood Pressure (20% or Greater Increase)
Sponsor
Konya City Hospital
Enrollment
110
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 2, 2024
End Date
July 20, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Konya City Hospital
Responsible Party
Principal Investigator
Principal Investigator

Mahmut Sami TUTAR

Associate Professor, Department of Anesthesiology and Reanimation

Konya City Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • The secondary aim of this study is to reveal the relationship between interscalene block and heart rate.(60 minute)

Study Sites (1)

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