CompletedNot Applicable

Influence of Thoracic Paravertebral Block on Atrioventricular Conduction

Poland60 participantsStarted 2025-02-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * use of beta-adrenolytic medications in 5 days preceding the intervention All exclusion criteria except the last one are based on the original study protocol (NCT05822076).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

P wave time

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

P wave minimal time

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

P wave maximal time

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

PR interval

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

PR minimal interval

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

PR maximal interval

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

Trial details

NCT IDNCT06833086

SponsorMedical University of Gdansk

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Conduction Abnormalities trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

P wave time

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

P wave minimal time

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

P wave maximal time

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

PR interval

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

PR minimal interval

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

PR maximal interval

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