Comparison of local anaesthesia and regional anaesthesia (PECS II block) on QoR-15 in patients undergoing subpectoral implantation of cardiac implantable electronic devices (CIEDs) - a Prospective, randomized, double-blinded, controlled pragmatic trial with two arms

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medizinische Universitaet Innsbruck

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

14 Oct 2024 → ongoing

Decision date (initial)

2024-09-20

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Medical University Innsbruck

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

The defined primary objective of the current study is the influence of PECS-II block versus local anaesthesia on comfort assessment in patients undergoing CIED – implantation, evaluated by the Quality of Recovery 15 Score (QoR-15), a patient-centred assessment of perioperative management quality.

Secondary objectives 2

1. Functioning of sufficient regional anaesthesia and the need for additional intra- and postoperative analgesia
2. The investigation of potential intra- and postoperative side effects of both interventions

Conditions and MedDRA coding

Need for a subpectoral implantation of cardiac implantable electronic devices (CIEDs)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients ≥ 18 years of age at time of consent
2. Ability to understand and willingness to sign and date written informed consent document.
3. Female participants of childbearing potential may be enrolled in the trial if the participant fulfils all the following criteria: a. Has a negative high-sensitivity pregnancy test at Screening and on the day of the first dose (Day 1). b. Is not currently breastfeeding

Exclusion criteria 10

1. Known intolerance to the IMP, auxiliary products or their components
2. Need for general anaesthesia
3. Subcutaneously implanted CIED
4. Opiate addiction and chronic pain patients
5. BMI less than 18 or greater than 35 (body weight <50kg)
6. Systemic infections
7. Local inflammation in the area of the injection site
8. Severe hepatic or renal insufficiency
9. Psychiatric concomitant diseases, which are associated with an altered perception and assessment of pain
10. Current/planned simultaneous participation in another interventional trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The difference in the Quality of Recovery 15 Score (QoR-15) assessed 24 hours after a subpectoral CIED

Secondary endpoints 9

1. intraoperative additional local anaesthetic administration
2. postoperative analgesic consumption
3. the need and dose of additional analgesia
4. VAS after 2, 4, 6, 12, and 24 hours
5. VAS-AUC and VAS groups < 30 mm / 30 - 60 mm / > 60 m
6. Data regarding hemodynamic stability, the duration of anaesthesia and intervention, any ICU stay, perioperative course of biomarkers (creatinine and troponin), and hospital length of stay
7. Changes in NYHA stage, LV-EF, and BMI
8. QoR-15 at 2 hours after CIED-implantation
9. Linear evolution of QoR-15

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medizinische Universitaet Innsbruck

Sponsor organisation

Medizinische Universitaet Innsbruck

Address

Innrain 52

City

Innsbruck

Postcode

6020

Country

Austria

Scientific contact point

Organisation

Medizinische Universitaet Innsbruck

Contact name

Department for Anaesthesiology and Intensive Care Medicine

Public contact point

Organisation

Medizinische Universitaet Innsbruck

Contact name

Department for Anaesthesiology and Intensive Care Medicine

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications