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Evaluation of the Effectiveness of Two Methods of Regional Anesthesia During S-ICD Implantation Procedure.

NCT06520150 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-07-25

No results posted yet for this study

Summary

Our study consists of a combination of regional blockade ('local' anesthesia) of the anterior and lateral chest wall in the form of a thin needle prick and the supply of local anesthetic drugs to the area of the relevant chest wall structures to exclude all stimuli, including pain from the operative site. A short-acting analgesic and sedative drug will be administered intravenously throughout the procedure - in a dose that allows the required contact between the patient and the anesthetist. If necessary, the dose of the drug may be increased to maintain pain comfort throughout the procedure.

The anesthetic team will be with the patient throughout the procedure to ensure comfort and safety.

Conditions

  • Chest Pain
  • Pain, Procedural
  • Pain, Postoperative
  • Analgesia
  • Regional Anesthesia Morbidity
  • Anesthesia, Local
  • ICD

Interventions

PROCEDURE

Regional anaesthetic combined fascial plane block

Prior to the procedure, the anaesthetists will receive an envelope from a person not related to the project (a hospital administrative staff member). This envelope will contain a randomly indicated method of anaesthesia based on simple randomisation. This will determine the type of regional block used during the procedure. It is important to note that the patient will not know which study group they have been classified in. Furthermore, the operator performing the procedure will not be informed of the type of anaesthesia performed. This is to ensure double-blinding. In order to ensure the highest standards of objectivity, the operator performing the procedure will not be informed about the type of block performed. This will allow us to assess the extent and quality of anaesthesia after the procedure, We will use a proprietary scale of subjective operator comfort scale.

DRUG

Ropivacaine 0.125% Injectable Solution +Lignocaine 0,25% Injectable Solution

administration under ultrasound guidance of a mixture of 2 local anaesthetics in a fixed total volume

Sponsors & Collaborators

  • 4th Military Clinical Hospital with Polyclinic, Poland

    lead OTHER

Principal Investigators

  • Marek Szamborski, MD · Senior Assistant

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-16
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06520150 on ClinicalTrials.gov