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Trial registered on ANZCTR

Registration number

ACTRN12621001386820

Ethics application status

Approved

Date submitted

8/02/2021

Date registered

14/10/2021

Date last updated

14/10/2021

Date data sharing statement initially provided

14/10/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Regional anesthesia techniques for subcutaneous implantable cardioverter-defibrillator (S-ICD) placement

Scientific title

Efficacy and safety of regional anesthesia techniques for subcutaneous implantable cardioverter-defibrillator (S-ICD) implant procedure using the combined block methods: pectoral nerve block type II (PECS I) and type II (PECS II) as well as serratus plane block (SPB)

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1263-2735

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Postoperative Pain

Cardiovascular Procedure

Regional anaesthesia

Pacemaker insertion

Condition category

Condition code

Anaesthesiology

Pain management

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The study aim is to assess the effectiveness and safety of regional anesthesia techniques for subcutaneous implantable cardioverter-defibrillator (S-ICD) implant procedure using the combined block methods including pectoral nerve block type II (PECS I) and type II (PECS II) as well as serratus plane block (SPB). All participants will receive all three regional anesthesia techniques (PACS I, PECS II, and SPB). All participants will receive a single injection of local anesthetics. All participants will receive scheduled blocks before the implantation procedure due to the various factors (the length of procedure, the availability of ultrasound, the availability of anesthetic and cardiologic team, the time between administration of the local anesthesia and start of S-ICD procedure will range from a minimum of 20 minutes to a maximum of 100 minutes, with an average waiting time of 55 minutes). The procedure will last from a minimum of 70 minutes to a maximum of 185 minutes, with an average waiting time of 95 minutes.

The project will be performed in the Department of Anesthesiology and Intensive Care of the 4th Military Hospital of Wroclaw in Poland. Adult patients of both sexes qualified for planned S-ICD implantation procedures will be included in the study.

Included patients will be subjected to a combined block method using PECS I, PECS II, and SPB. PECS I and II are compartmental thoracic wall blocks, commonly used as one of the components of multimodal analgesia for anterior and lateral thoracic procedures.

PECS I is a compartmental block, in which a local anesthetic is deposited between the major and minor pectoral muscles blocking the lateral and medial pectoral nerves. Stages of PECS I anesthesia:
1. Skin cleaning according to aseptic principles.
2. The linear ultrasound head, initially located in the midclavicular line at the level of the 3rd rib, moves laterally and identifies the following structures: the pectoralis major (PMA) and minor (PMI) muscles, the serratus anterior (SA) muscle (located below the PMI muscle), the intercostal muscles.
3. The block is usually performed using the in-plane technique, inserting the needle from the medial side and directing it to the rib.
4. Local anesthetic is deposited at the level of 3 ribs, between the fascia of the PMA and PMI muscles, in order to obtain a characteristic separation of both muscles.
5. Identification of the correct needle end position by applying 5-10ml 0,125% Ropimol +0,25% Lignocaine solution.

PECS II is a modification of the PECS I blockade, in which, after deposition of the anesthetic between the PMA and PMI muscles, the additional dose of local anesthetics is spilled between the PMA and PMI muscles and the SA muscle or below SA muscle, blocking the lateral branches of the Th2-4 intercostal nerves, the intercostobrachial nerve, and the long thoracic nerve. Stages of PECS II:
1. After the PECS I block, the needle is guided deeper, depositing another dose of the anesthetic between the PMA and PMI muscles and below located the SA muscle.
2. Identification of the correct needle end position by applying 10-15ml 0,125% Ropimol +0,25% Lignocaine solution.

SBP is a compartmental thoracic block, which involves the deposition of local anesthesia at the Th5 vertebrae between the middle and posterior axillary lines, in the interfacial interval between the latissimus dorsi (LD) muscle and SA muscle. The range of the block includes the Th3-Th9 intercostal nerve and the thoracodorsal nerve. The whole procedure will be ultrasound-guided using the EchoPlex 22G (50mm, 75mm) (VYGON). Stages of SBP:
1. Skin cleaning according to aseptic principles.
2. The linear ultrasound head is located in the frontal plane at the level of Th5 vertebrae between the central and posterior axillary lines.
3. The block is usually performed using the in-plane technique, inserting the needle from the caudal side and directing it to the rib.
4. Identification of the correct needle end position by applying 20-30ml 0,125% Ropimol +0,25% Lignocaine solution.

The detailed procedure of the anesthesia:
Local anesthesia with a soaked 5-10ml Lignocaine 1% with adrenaline administered subcutaneously (1-2 cm) between II-V ribs. Additionally, during anesthesia a superficial intravenous analgosedation is used with the possibility of contact with the operated person, the operator performs local anesthesia of the parasternal region with a small volume of short-acting local analgesic.

The person performing both procedures will be the same anesthesiologist with at least 3 years of professional expertise, including a minimum of 50 PECS I, PECS II, and SPB.

The course of the procedure:
A patient classified for S-ICD implantation is qualified for scheduled anesthesia. The patient signs the anesthesiological agreement and consent to participate in the study. The patient remains fasting for 6 hours before the procedure. For 40 minutes before arrival in the preparation room/surgery room, the patient receives the recommended premedication. This will normally be 150 mg Pregabalin orally and 1g Paracetamol orally. After the patient is monitored, the scheduled blockade is performed.

At the end of the procedure, intravenous anesthesia is performed to test the device - ventricular fibrillation (VF) release and electrotherapy. After the procedure, the patient requires 2 hours of observation due to the analgosedation performed. During this time the analgesic effect of the block will be assessed. Adverse events that occurred during the patient's stay will be noted, such as postoperative delirium, excessive sleepiness, significant pain, early complications such as bleeding or arrhythmias. The total time of hospitalization will be recorded.

Importantly, during the postoperative period, coanalgesics will be used according to the standard: Paracetamol (Acetaminophen) 0-1.0 g intravenously every 6-8 hours, Metamizole 0-2.5 g intravenously every 12 hours, Ketoprofen 0-100 mg intravenously every 12 hours. In case of allergy or any contraindications to the above-mentioned medications will be excluded.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Treatment: Drugs

Intervention code [3]

Prevention

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The severity of pain assessed by the patient by means of the Numerical Rating Scale (NRS)

Timepoint [1]

Baseline, intraoperative, postoperative 6 hours, 12 hours (primary endpoint), 24 hours

Primary outcome [2]

The severity of pain assessed by the patient by means of the Visual Analogue Scale (VAS)

Timepoint [2]

Baseline, intraoperative, postoperative 6 hours, 12 hours (primary endpoint), 24 hours

Primary outcome [3]

The quality of postoperative recovery assessed by the patient by means of the Quality-of-Recovery 15 (QoR-15)

Timepoint [3]

Baseline, intraoperative, postoperative 6 hours, 12 hours (primary endpoint), 24 hours

Secondary outcome [1]

Composite secondary outcome: the level of selected vital signs in the clinical monitoring of hemodynamic stability and effectiveness of anesthesia: heart rate measured using electrocardiography, blood pressure measured using a sphygmomanometer, oxygen saturation measured using a pulse oximeter.

Timepoint [1]

Baseline, intraoperative every 15 minutes of the procedure, and postoperative15 minutes, 30 minutes, 45 minutes, and 60 minutes..

Secondary outcome [2]

Requirement for use of coanalgesics by accessing patient medical record

Timepoint [2]

Baseline, postoperative 6 hours, 12 hours,18 hours, 24 hours, 36 hours, and 48 hours

Secondary outcome [3]

The quality of the operator according to conditions during the combined block method using PECS I, PECS II, and SPB assessed by means of the Operator's Condition Assessment Score which was designed specifically for this study

Timepoint [3]

Intreoperatively

Eligibility

Key inclusion criteria

1. Age > 18 years old and < 90 years old
2. Classification of the American Society of Anesthesiologists (ASA) III/IV
3. The obtained informed and written consent to participate in the study

Minimum age

18 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Non-acceptance for regional anesthesia
2. Allergy to local anesthetic drugs
3. Serious coagulopathy PLT <50x10^3, INR>2,5 APTT>40sec
4. Infection in puncture area

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Continuously distributed data will be tested for normality and measures of central tendency will be analyzed. Normally distributed data will be expressed as means and standard deviations and compared using a Student t-test; non-normally distributed data will be expressed as medians (interquartile range, IQR) and compared using the Mann-Whitney U test. Categorical variables will be described as proportions and compared using the chi-squared test or the Fisher Exact test. The strength of the relationship will be evaluated with the Spearman rank correlation coefficient. All p-values of less than 0.05 will be treated as indicative as statistical significance and no correction for multiplicity of testing will be undertaken due to the exploratory nature of the study. The study will be reported using the CONSORT guidelines. Analyses will be performed using GraphPad Prism (version 7.00 for Mac, GraphPad Software, La Jolla California USA).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

18/10/2021

Actual

Date of last participant enrolment

Anticipated

1/04/2022

Actual

Date of last data collection

Anticipated

7/04/2022

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Lower Silesia

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

4th Military Hospital of Wroclaw, Poland

Address [1]

Weigla 5, 50-981 Wroclaw, Poland

Country [1]

Poland

Primary sponsor type

University

Name

Wroclaw Medical University, Poland

Address

Pasteura 1, 50-367 Wroclaw

Country

Poland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bioethics Committee at The Military Medical Chamber in Warsaw

Ethics committee address [1]

Jelinka 48, 01-646 Warsaw, Poland

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

22/12/2020

Approval date [1]

26/01/2021

Ethics approval number [1]

KB–2/21

Summary

Brief summary

The aim of this study is to assess the effectiveness of combine regional anesthesia for S-ICD implantation, and part of the postoperative treatment of pain in patients after S-ICD implantation. Cardiovascular implantation was performed mainly by general anesthesia which proves a novelty of this study.

The occurrence of severe pain in the postoperative period affects worsened wound healing, prolonged hospitalization, may lead to pneumonia, and create additional treatment costs. In addition, in the context of postoperative abuse of opioid drugs, it is an alternative to analgesia and leads to a reduction in the use of opioid drugs and the occurrence of related side effects.

The researchers assume that the experimental PECS I/II +SBP procedure will significantly reduce the severity of patient pain, decrease the need for co-analgesics and opioids, and diminish the risk of side effects and postoperative complications.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Marek Szamborski, MD

Address

Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland

Country

Poland

Phone

+48 698448639

Fax

[email protected]

Contact person for public queries

Name

Mr Marek Szamborski, MD

Address

Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland

Country

Poland

Phone

+48 698448639

Fax

[email protected]

Contact person for scientific queries

Name

Dr Patrycja Lesnik, MD, PhD

Address

Department of Anesthesiology and Intensive Care, 4th Military Hospital of Wroclaw, Weigla 5, 50-981 Wroclaw, Poland

Country

Poland

Phone

+48 691840822

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual participant data underlying published results only

When will data be available (start and end dates)?

Available for 5 years after publication

Available to whom?

Only to researchers who provide a methodologically relevant explanation

Available for what types of analyses?

Only to achieve the purposes of the approved request

How or where can data be obtained?

The data can be obtained by emailing the principal investigator ([email protected])

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10476	Ethical approval					381378-(Uploaded-08-02-2021-08-05-57)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Regional Anesthesia for the Implantation of a Subcutaneous Implantable Cardioverter-Defibrillator Using Pectoserratus Plane Block and Superficial Serratus Anterior Plane Block.	2023	https://dx.doi.org/10.12659/MSM.940541

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically