Influence of Thoracic Paravertebral Block on Atrioventricular Conduction

NCT06833086 | Completed

• 1 other identifier: KB/35/2025
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the changes in electrical activity of heart atria and in atrioventricular conduction induced by anaesthetic thoracic paravertebral blockade, depending on site on which blockade was performed. Researchers will retrospectively compare ECG recordings of patients that undergone unilateral paravertebral blockade at T3 level with 0.5% ropivacaine. The investigation will include measurement of P wave and PR interval, and subsequent statystical analysis.

Conditions

Conduction Abnormalities; Paravertebral Anesthesia

Keywords

P wave; PR interval; PQ interval; P wave dispersion; Paravertebral block; Atrioventricular conduction; Ropivacaine

Outcome Measures

Primary Outcomes (6)

• P wave time

  difference in milliseconds of P wave time (as a mean from all measured leads) between baseline ECG \[T0\] and ECG after confirmation of sufficient area of sensory block \[T1\]

  from 6 up to 15 minutes (according to time of developement of sufficient block distribution)

• P wave minimal time

  difference in milliseconds of shortest P wave time (from all measured leads) between baseline ECG \[T0\] and ECG after confirmation of sufficient area of sensory block \[T1\]

  from 6 up to 15 minutes (according to time of developement of sufficient block distribution)

• P wave maximal time

  difference in milliseconds of longest P wave time (from all measured leads) between baseline ECG \[T0\] and ECG after confirmation of sufficient area of sensory block \[T1\]

  from 6 up to 15 minutes (according to time of developement of sufficient block distribution)

• PR interval

  difference in milliseconds of PR interval (as a mean from all measured leads) between baseline ECG \[T0\] and ECG after confirmation of sufficient area of sensory block \[T1\]

  from 6 up to 15 minutes (according to time of developement of sufficient block distribution)

• PR minimal interval

  difference in milliseconds of PR minimal interval (from all measured leads) between baseline ECG \[T0\] and ECG after confirmation of sufficient area of sensory block \[T1\]

  from 6 up to 15 minutes (according to time of developement of sufficient block distribution)

• PR maximal interval

  difference in milliseconds of PR maximal interval (from all measured leads) between baseline ECG \[T0\] and ECG after confirmation of sufficient area of sensory block \[T1\]

  from 6 up to 15 minutes (according to time of developement of sufficient block distribution)

Secondary Outcomes (3)

• P wave dispersion

  from 6 up to 15 minutes (according to time of developement of sufficient block distribution)

• P wave index

  from 6 up to 15 minutes (according to time of developement of sufficient block distribution)

• PR interval dispersion

  from 6 up to 15 minutes (according to time of developement of sufficient block distribution)

Study Arms (2)

L - paravertebral block left

30 woman above 18 years of age qualified for elective breast surgery on the left side of the body

Procedure: Paravertebral block (ropivacaine) left

P - paravertebral block right

30 woman above 18 years of age qualified for elective breast surgery on the right side of the body

Procedure: Paravertebral block (ropivacaine) right

Interventions

Paravertebral block (ropivacaine) left PROCEDURE

Paravertebral block at the level of 3rd thoracic intervertebral space on the left side. 0.5% Ropivacaine 0.3 ml·kg-1, not exceeding 30 ml, based on ideal body weight in obese patients

L - paravertebral block left

Paravertebral block (ropivacaine) right PROCEDURE

Paravertebral block at the level of 3rd thoracic intervertebral space on the right side. 0.5% Ropivacaine 0.3 ml·kg-1, not exceeding 30 ml, based on ideal body weight in obese patients

P - paravertebral block right

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women above 18 years of age, without severe systemic comorbidities, patients of University Clinical Centre of Medical University of Gdańsk qualified for elective breast surgery

You may qualify if:

• woman above 18 years of age, legally able of giving informed consent
• participants previously qualified for elective breast surgery due to neoplasm, with or without axillary node dissection
• physical status corresponding to class I or II in American Society of Anaesthesiologist classification

You may not qualify if:

• lack of consent to participation or to regional anaesthesia for planned surgery
• bilateral operation planned
• symptomatic circulatory disease at the time of qualification, artificial heart pacemaker presence, positive history of arrythmia
• allergy to amide local anaesthetics
• severe deformation of thoracic spine
• use of medications with "known" or "possible" potential of QT prolongation, according to Arizona Center for Education and Research on Therapeutics \[AZCERT\] Inc. list, in 5 days preceding the intervention

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Gdański Uniwersytet Medyczny

Gdansk, Poland

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: February 20, 2025
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

PL (1)