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

NCT06520150 | Recruiting

• 1 other identifier: 3_2024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Superficial Serratus Anterior Plane Block (SSAP); Superficial Parasternal Intercostal Plane Block (SPIP); Pectoserratus Plane Blocks (PSP); Regional anaesthesia; Subcutaneous implantable defibrillator (S-ICD); thorax blockade; less invasive; implantation; pain treatment

Outcome Measures

Primary Outcomes (6)

• NRS

  numerical pain scale 0-10 points

  Checked at regular 15-minute intervals during the procedure and every 6 hours for the first 24 hours after the procedure

• VAS

  visual analogue scale 0-10 points

  Checked at regular 15-minute intervals during the procedure and every 6 hours for the first 24 hours after the procedure

• QoR - 15

  post-operative quality of life and improvement scale 0-150 points

  Administered to the patient before surgery and 24 hours after surgery

• RASS

  Richmond arousal/sedation scale) (-5 \<-\>+5) points

  Checked at regular 15 minute intervals during the procedure

• GCS

  Glasgow level of consciousness score scales 3-15 points

  Checked at regular 15 minute intervals during the procedure

• EOA

  Effectiveness of Anaesthesia) -scale (-3 do +3) points

  Checked immediately after the procedure (last suture)

Secondary Outcomes (3)

• SpO2

  Monitored every 5 minutes during the procedure

• NIBP

  Monitored every 5 minutes during the procedure

• HR

  Monitored every 5 minutes during the procedure

Other Outcomes (2)

• BMI

  Before performing procedure

• bioimpedance

  beforeperforming procedure

Study Arms (2)

Group I (PSP+SSAP)

ACTIVE COMPARATOR

Group I will include patients undergoing PSP(Pectoserratus plane block)+SSAP(Superficial serratus anterior plane block) (20+40ml) The solution is defined as a combination of 0.125% ropivacaine solution with 0.25% lidocaine solution in a total volume of 60ml of liquid administered.

Procedure: Regional anaesthetic combined fascial plane block; Drug: Ropivacaine 0.125% Injectable Solution +Lignocaine 0,25% Injectable Solution

Group I (SPIP+SSAP)

ACTIVE COMPARATOR

Group II will include patients undergoing SPIP(Superficial parastenal intercostal plane block)+SSAP(Superficial serratus anterior plane block) (20+40ml) The solution is defined as a combination of 0.125% ropivacaine solution with 0.25% lidocaine solution in a total volume of 60ml of liquid administered.

Procedure: Regional anaesthetic combined fascial plane block; Drug: Ropivacaine 0.125% Injectable Solution +Lignocaine 0,25% Injectable Solution

Interventions

Regional anaesthetic combined fascial plane block PROCEDURE

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.

Also known as: PSP, SPIP, SSAP

Group I (PSP+SSAP); Group I (SPIP+SSAP)

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

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

Group I (PSP+SSAP); Group I (SPIP+SSAP)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18-90 years requiring S-ICD implantation for cardiac indications,
• high risk of anesthesia (ASA II or higher), patients giving informed consent to participate in the study.

You may not qualify if:

• absolute contraindications to regional anesthesia such as generalized coagulation disorders, inflammation at the site of anesthesia, allergy to the drugs used for regional anesthesia
• lack of consent of the patient for the conducted procedure,
• inability to cooperate with the patient - such as severe mental retardation, unregulated mental illness with motor agitation, advanced neurodegenerative diseases such as Parkinson's disease/Alzheimer's,
• inability to give informed consent to participate in the study.

Sponsors & Collaborators

• 4th Military Clinical Hospital with Polyclinic, Poland: lead

Study Sites (1)

4th Military Clinical Hospital with Polyclinic

Wroclaw, Lower Silesian Voivodeship, 50-981, Poland

RECRUITING

MeSH Terms

Conditions

Chest Pain; Pain, Procedural; Pain, Postoperative; Agnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Marek Szamborski, MD

  Senior Assistant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marek Szamborski, MD

CONTACT

698448639; mszamborski@4wsk.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Anesthesiologists administering anesthesia prior to surgery receive an envelope with a randomly indicated method of anesthesia based on simple randomization determines the type of regional blockade used during the procedure). The subject will not know which study group he or she has been classified into. The operator performing the procedure will not be informed of the type of anesthesia performed -\[randomization by double-blinding\]. The operator performing the procedure will not be informed about the type of block performed in order to objectivize the extent and quality of the subject's anesthesia, which he will evaluate after the procedure according to a scale of subjective operator comfort created (EOA scale).
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Assistant, MD

Model Details: The subjects will be randomly divided into 2 groups - Group I will be patients administered PSP+SSAP anesthesia (consecutively 20+40ml of the mixture indicated above). Group II will be patients given SPIP+SSAP blockade (consecutively 20+40ml of the mixture indicated above). It was tentatively planned to conduct the study on a group of 32 patients (16 in each of the two groups).

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 25, 2024
• Study Start: June 16, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

PL (1)