Influence of Thoracic Paravertebral Block on Cardiac Repolarization

NCT05822076 | Completed

• 1 other identifier: NKBBN/948/2022
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Paravertebral Block; QT Interval

Keywords

QT Interval; Transmural dispersion of repolarization; Paravertebral block

Outcome Measures

Primary Outcomes (3)

• QT interval

  difference in milliseconds of QT interval between baseline ECG \[T0\] and ECG after confirmation of sufficient area of sensory block \[T1\]

  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 \[T1\]

  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 \[T1\]

  during procedure (6 minutes (prolonged until sufficient block distribution is achieved up to 15 minutes))

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
• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care

Gdansk, 80-214, Poland

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Radosław Owczuk, MD, PhD

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Head of Department of Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: February 2, 2023
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

PL (1)