Conduction AbnormalitiesNCT06833086
Influence of Thoracic Paravertebral Block on Atrioventricular Conduction
An observational study of Conduction Abnormalities and Paravertebral Anesthesia, run by Medical University of Gdansk at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Conduction Abnormalities, Paravertebral Anesthesia
- What is being tested?
- Paravertebral block (ropivacaine) left and Paravertebral block (ropivacaine) right
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 20 Feb 2025to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Influence of Thoracic Paravertebral Block on Atrioventricular Conduction
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.
Read the detailed description
Paravertebral blockade (PVB), the injection of local anaesthetic into the paravertebral space located along the vertebral column, temporarily impair the transmission in nerve fibers located in this space. Although PVB is usually used primarily with the intention of achieving block of the thoracic wall pain sensation, the paravertebral space contains not only motoric and sensory nerves, but also autonomic nerve fibers. Achieving the blockade at top four thoracic levels of paravertebral space may affect, among the others, the function of preganglionic sympathetic fibers, forming cardiac nerves, and affecting the heart function in various ways.
The assessment of electrocardiographical phenomena representing the depolarisation of the atria (P wave) and the propagation of the depolarisation by the atrioventricular node and bundle (PQ/PR interval) allows to detect the abnormalities related to proability of occurrence of supraventricular arrythmias and conduction blocks, including the life-threatening arrythmias.
The design of the study assume to retrospective re-analyse the electrocardiographical data achieved in the "Influence of Thoracic Paravertebral Block on Cardiac Repolarization" study (registred in Clinicaltrials.gov under ID NCT05822076), focused changes in heart repolarisation represented mainly by electrocardiographical QT interval and T wave dispersion.
The population of primary investigation was 60 women above 18 years of age scheduled to elective breast surgery in combined regional and general anaesthesia will be enrolled to study, divided in two groups depending of the side of operation. Participants underwent the ultrasound-guided paravertebral block with single injection of 0.5% ropivacaine (0.3 ml·kg-1, not exceeding 30 ml, based on ideal body weight in obese patients) without adjuvants. Before injection (T0) and after confirmation of sufficient sensory block area covering 1st to 4th thoracic dermatomes (T1), 12-lead electrocardiogram (ECG) will be recorded using a Holter device. First examination of sensory block distribution was performed 6 minutes after injection, with subsequent examinations if needed - every minute up to 15 minutes. No sedative premedication, general anaesthesia induction or additional medications (except of neutral saline maintaining intravenous access) were administered until completions of ECG recording. Both T0 and T1 electrocardiogram will be preceded by rest in supine position for at least 5 minutes, without any medical procedures other than monitoring.
As part of the retrospective analysis of ECG recordings obtained from the primary study, repeated measurements will be performed to assess the length of the P wave and the PQ interval at time points T0 and T1, taken as the average of three subsequent heart evolutions and measured separately for each lead. Only cases in which ECG waveform without significant artifact or interferences was obtained in at least 8 leads in both T0 and T1 will be analyzed.
From the obtained values, the P wave dispersion will be calculated (as the difference in the length of the P wave in two leads in which the average time of three evolutions was the longest and the shortest) and the PQ dispersion (as the difference in the length of the PQ interval in two leads in which the average time of three evolutions was the longest and the shortest). The obtained data will be subjected to statistical analysis taking into account the side of the body on which the intervention was performed.
- Conditions
- Conduction Abnormalities, Paravertebral Anesthesia
- Being tested
- Paravertebral block (ropivacaine) left, Paravertebral block (ropivacaine) right
- Keywords
- P wave, PR interval, PQ interval, P wave dispersion, Paravertebral block, Atrioventricular conduction, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral block (ropivacaine) leftProcedure or surgery
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
Paravertebral block (ropivacaine) rightProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| L - paravertebral block left | 30 woman above 18 years of age qualified for elective breast surgery on the left side of the body Receives: 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 Receives: Procedure: Paravertebral block (ropivacaine) right |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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]
Measured: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)
Secondary outcomes (3)
P wave dispersion
difference in milliseconds of P wave dispersion (calculated as a difference between the longest and shortest P wave time from all measured leads) between baseline ECG [T0] and ECG after confirmation of sufficient area of sensory block [T1]
Measured: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)
P wave index
difference of standard deviations from P wave durations (from all measured leads) between baseline ECG [T0] and ECG after confirmation of sufficient area of sensory block [T1]
Measured: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)
PR interval dispersion
difference in milliseconds of PR interval dispersion (calculated as a difference between the longest and shortest PR interval from all measured leads) between baseline ECG [T0] and ECG after confirmation of sufficient area of sensory block [T1]
Measured: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start20 Feb 2025
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduction AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radosław Owczuk, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833086
- Sponsor's protocol ID
- KB/35/2025
- Status last verified
- Apr 2025
- First submitted
- 12 Feb 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Influence of Thoracic Paravertebral Block on Atrioventricular Conduction
- ClinicalTrials.gov ID
- NCT06833086
- Acronym / sponsor ID
- KB/35/2025
- Conditions
- Conduction Abnormalities, Paravertebral Anesthesia
- Keywords
- P wave, PR interval, PQ interval, P wave dispersion, Paravertebral block, Atrioventricular conduction, Ropivacaine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Paravertebral blockade (PVB), the injection of local anaesthetic into the paravertebral space located along the vertebral column, temporarily impair the transmission in nerve fibers located in this space. Although PVB is usually used primarily with the intention of achieving block of the thoracic wall pain sensation, the paravertebral space contains not only motoric and sensory nerves, but also autonomic nerve fibers. Achieving the blockade at top four thoracic levels of paravertebral space may affect, among the others, the function of preganglionic sympathetic fibers, forming cardiac nerves, and affecting the heart function in various ways.
The assessment of electrocardiographical phenomena representing the depolarisation of the atria (P wave) and the propagation of the depolarisation by the atrioventricular node and bundle (PQ/PR interval) allows to detect the abnormalities related to proability of occurrence of supraventricular arrythmias and conduction blocks, including the life-threatening arrythmias.
The design of the study assume to retrospective re-analyse the electrocardiographical data achieved in the "Influence of Thoracic Paravertebral Block on Cardiac Repolarization" study (registred in Clinicaltrials.gov under ID NCT05822076), focused changes in heart repolarisation represented mainly by electrocardiographical QT interval and T wave dispersion.
The population of primary investigation was 60 women above 18 years of age scheduled to elective breast surgery in combined regional and general anaesthesia will be enrolled to study, divided in two groups depending of the side of operation. Participants underwent the ultrasound-guided paravertebral block with single injection of 0.5% ropivacaine (0.3 ml·kg-1, not exceeding 30 ml, based on ideal body weight in obese patients) without adjuvants. Before injection (T0) and after confirmation of sufficient sensory block area covering 1st to 4th thoracic dermatomes (T1), 12-lead electrocardiogram (ECG) will be recorded using a Holter device. First examination of sensory block distribution was performed 6 minutes after injection, with subsequent examinations if needed - every minute up to 15 minutes. No sedative premedication, general anaesthesia induction or additional medications (except of neutral saline maintaining intravenous access) were administered until completions of ECG recording. Both T0 and T1 electrocardiogram will be preceded by rest in supine position for at least 5 minutes, without any medical procedures other than monitoring.
As part of the retrospective analysis of ECG recordings obtained from the primary study, repeated measurements will be performed to assess the length of the P wave and the PQ interval at time points T0 and T1, taken as the average of three subsequent heart evolutions and measured separately for each lead. Only cases in which ECG waveform without significant artifact or interferences was obtained in at least 8 leads in both T0 and T1 will be analyzed.
From the obtained values, the P wave dispersion will be calculated (as the difference in the length of the P wave in two leads in which the average time of three evolutions was the longest and the shortest) and the PQ dispersion (as the difference in the length of the PQ interval in two leads in which the average time of three evolutions was the longest and the shortest). The obtained data will be subjected to statistical analysis taking into account the side of the body on which the intervention was performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L - paravertebral block left | – | Procedure: Paravertebral block (ropivacaine) left30 woman above 18 years of age qualified for elective breast surgery on the left side of the body |
| P - paravertebral block right | – | Procedure: Paravertebral block (ropivacaine) right30 woman above 18 years of age qualified for elective breast surgery on the right side of the body |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paravertebral block (ropivacaine) leftParavertebral 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 | Procedure or surgery | L - paravertebral block left |
| Paravertebral block (ropivacaine) rightParavertebral 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 | Procedure or surgery | P - paravertebral block right |
Primary outcome
P wave time
Time frame: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)
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]
P wave minimal time
Time frame: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)
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]
P wave maximal time
Time frame: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)
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]
PR interval
Time frame: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)
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]
PR minimal interval
Time frame: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)
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]
PR maximal interval
Time frame: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)
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]
3 secondary outcomes
P wave dispersion
Time frame: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)
P wave index
Time frame: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)
PR interval dispersion
Time frame: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conduction Abnormalities and Paravertebral Anesthesia, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P wave time (time frame: from 6 up to 15 minutes (according to time of developement of sufficient block distribution)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.