Paravertebral BlockNCT05822076
Influence of Thoracic Paravertebral Block on Cardiac Repolarization
An observational study of Paravertebral Block and QT Interval, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Aim of the study is to determine the presence and direction of electrocardiographical changes of cardiac repolarization after thoracic paravertebral block, depending on block laterality. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Paravertebral Block, QT Interval
- 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
- 2 Feb 2023to 5 Jun 2024
- 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
- 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
- severe deformation of thoracic spine
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care
Gdansk, 80-214
About this study
Official title: Evaluation of Influence of Thoracic Paravertebral Block on Cardiac Repolarization
Aim of the study is to determine the presence and direction of electrocardiographical changes of cardiac repolarization after thoracic paravertebral block, depending on block laterality.
Injection of local anaesthetic into paravertebral space (paravertebral block, PVB) temporarily impairs transmission in nerve fibers in proximity of the deposition site. In case of PVB covering the rami of upper thoracic spinal nerves, among the others thoracic sympathetic cardiac nerves are blocked, possibly affecting action potential time of heart, especially the repolarization, and the related electrocardiographic phenomena.
The risk of life-threatening polymorphic ventricular tachycardia (torsade des pointes, TdP) is associated with certain electrocardiographical symptoms, like QT interval prolongation and increased transmural repolarization dispersion (TDR). Determining the presence and direction of cardiac repolarization changes after a thoracic PVB will allow to conclude about its impact on TdP risk: protective or, contrary, arrhythmogenic.
Read the detailed description
After obtaining written informed consent, 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 will undergo 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 will be 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) will be 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. Cases with baseline QT or corrected QT longer than 440 milliseconds (ms) will be excluded from study.
The QT interval and TDR (measured as time in milliseconds between ECG T wave peak [Tpeak] and end [Tend]) values obtained from baseline and post-blockade electrocardiograms will be statistically analyzed and compared between study groups.
The minimum sample size was calculated as 26 cases per study group, assuming a change in corrected QT of 20 milliseconds from the baseline value, with a significance level of p=0.05 and a test power of 0.9. Sample size was expanded to 30 cases per group, due to anticipated exclusions at the stage of intervention or data analysis.
- Conditions
- Paravertebral Block, QT Interval
- Being tested
- Paravertebral block (ropivacaine) left, Paravertebral block (ropivacaine) right
- Keywords
- QT Interval, Transmural dispersion of repolarization, Paravertebral block
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.
QT interval
difference in milliseconds of QT interval between baseline ECG [T0] and ECG after confirmation of sufficient area of sensory block [T1]
Measured: during procedure (6 minutes (prolonged until sufficient block distribution is achieved up to 15 minutes))
Corrected QT interval
difference in milliseconds of QT interval corrected [according to Bazett, Framingham, Fredericia formulas] between baseline ECG [T0] and ECG after confirmation of sufficient area of sensory block [T1]
Measured: during procedure (6 minutes (prolonged until sufficient block distribution is achieved up to 15 minutes))
Tpeak-Tend
difference in milliseconds of Tpeak-Tend time between baseline ECG [T0] and ECG after confirmation of sufficient area of sensory block [T1]
Measured: during procedure (6 minutes (prolonged until sufficient block distribution is achieved up to 15 minutes))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start2 Feb 2023
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paravertebral BlockStudies 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
- Prospective
- 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
- Investigators
- Radosław Owczuk, MD, PhD, Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822076
- Sponsor's protocol ID
- NKBBN/948/2022
- Status last verified
- Aug 2024
- First submitted
- 7 Apr 2023
- Last updated
- 16 Aug 2024
- 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 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Influence of Thoracic Paravertebral Block on Cardiac Repolarization
- ClinicalTrials.gov ID
- NCT05822076
- Acronym / sponsor ID
- NKBBN/948/2022
- Conditions
- Paravertebral Block, QT Interval
- Keywords
- QT Interval, Transmural dispersion of repolarization, Paravertebral block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 20 Apr 2023 (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.
Aim of the study is to determine the presence and direction of electrocardiographical changes of cardiac repolarization after thoracic paravertebral block, depending on block laterality.
Injection of local anaesthetic into paravertebral space (paravertebral block, PVB) temporarily impairs transmission in nerve fibers in proximity of the deposition site. In case of PVB covering the rami of upper thoracic spinal nerves, among the others thoracic sympathetic cardiac nerves are blocked, possibly affecting action potential time of heart, especially the repolarization, and the related electrocardiographic phenomena.
The risk of life-threatening polymorphic ventricular tachycardia (torsade des pointes, TdP) is associated with certain electrocardiographical symptoms, like QT interval prolongation and increased transmural repolarization dispersion (TDR). Determining the presence and direction of cardiac repolarization changes after a thoracic PVB will allow to conclude about its impact on TdP risk: protective or, contrary, arrhythmogenic.
Detailed description
After obtaining written informed consent, 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 will undergo 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 will be 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) will be 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. Cases with baseline QT or corrected QT longer than 440 milliseconds (ms) will be excluded from study.
The QT interval and TDR (measured as time in milliseconds between ECG T wave peak [Tpeak] and end [Tend]) values obtained from baseline and post-blockade electrocardiograms will be statistically analyzed and compared between study groups.
The minimum sample size was calculated as 26 cases per study group, assuming a change in corrected QT of 20 milliseconds from the baseline value, with a significance level of p=0.05 and a test power of 0.9. Sample size was expanded to 30 cases per group, due to anticipated exclusions at the stage of intervention or data analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- 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 (6 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
- 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
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
QT interval
Time frame: during procedure (6 minutes (prolonged until sufficient block distribution is achieved up to 15 minutes))
difference in milliseconds of QT interval between baseline ECG [T0] and ECG after confirmation of sufficient area of sensory block [T1]
Corrected QT interval
Time frame: during procedure (6 minutes (prolonged until sufficient block distribution is achieved up to 15 minutes))
difference in milliseconds of QT interval corrected [according to Bazett, Framingham, Fredericia formulas] between baseline ECG [T0] and ECG after confirmation of sufficient area of sensory block [T1]
Tpeak-Tend
Time frame: during procedure (6 minutes (prolonged until sufficient block distribution is achieved up to 15 minutes))
difference in milliseconds of Tpeak-Tend time between baseline ECG [T0] and ECG after confirmation of sufficient area of sensory block [T1]
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 16 Aug 2024.
- 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.
Radosław Owczuk, MD, PhD principal investigator
Medical University of Gdansk
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 Paravertebral Block and QT Interval, 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 6 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 16 Aug 2024. 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?
QT interval (time frame: during procedure (6 minutes (prolonged until sufficient block distribution is achieved up to 15 minutes))). The study lists 3 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 16 Aug 2024.