Factors Predicting Blood Pressure Change With Interscalene Block

Completed

• Conditions: Systolic Blood Pressure (20% or Greater Increase)

• Registration Number: NCT06394960
• Lead Sponsor: Konya City Hospital

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.

Study Timeline

• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-01
• Study Start: 2024-05-02
• Status Verified: 2024-07
• Primary Completion: 2024-07-10
• Study Completion: 2024-07-20
• Last Update Submitted: 2024-07-20
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

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

Trial Locations

Locations (1)

Konya City Hospital; 🇹🇷 Konya, Karatay, Turkey