Factors Predicting Blood Pressure Change With Interscalene Block

July 20, 2024 updated by: Mahmut Sami TUTAR, Konya City Hospital

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Karatay
      • Konya, Karatay, Turkey, 42020
        • Konya City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The participating study center will be Konya City Hospital and the research population will consist of volunteer patients who will undergo elective shoulder surgery under interscalene block.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2024

Primary Completion (Actual)

July 10, 2024

Study Completion (Actual)

July 20, 2024

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 20, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13.11.2023-22850

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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