Factors Predicting Blood Pressure Change With Interscalene Block

NCT ID: NCT06394960

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-02

Study Completion Date

2024-07-20

Brief Summary

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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

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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.

Conditions

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Systolic Blood Pressure (20% or Greater Increase)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Konya City Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mahmut Sami TUTAR

Associate Professor, Department of Anesthesiology and Reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Konya City Hospital

Konya, Karatay, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Tutar MS, Polat A, Korkmaz R, Aksoy I, Dogar F, Yildirim A, Satici MH, Yildiz M, Kozanhan B. Prediction of hypertensive responses associated with interscalene block, a prospective cohort study. BMC Anesthesiol. 2025 Feb 19;25(1):82. doi: 10.1186/s12871-025-02947-w.

Reference Type DERIVED
PMID: 39972410 (View on PubMed)

Other Identifiers

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13.11.2023-22850

Identifier Type: -

Identifier Source: org_study_id

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