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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
EU CTIS ID: 2023-508997-27-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥ 18 years of age at time of consent
- Ability to understand and willingness to sign and date written informed consent document.
- 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
You likely can't join if
- Known intolerance to the IMP, auxiliary products or their components
- Current/planned simultaneous participation in another interventional trial
- Need for general anaesthesia
- Subcutaneously implanted CIED
- Opiate addiction and chronic pain patients
- BMI less than 18 or greater than 35 (body weight <50kg)
See the full eligibility criteria
- Patients ≥ 18 years of age at time of consent
- Ability to understand and willingness to sign and date written informed consent document.
- 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
- Known intolerance to the IMP, auxiliary products or their components
- Current/planned simultaneous participation in another interventional trial
- Need for general anaesthesia
- Subcutaneously implanted CIED
- Opiate addiction and chronic pain patients
- BMI less than 18 or greater than 35 (body weight <50kg)
- Systemic infections
- Local inflammation in the area of the injection site
- Severe hepatic or renal insufficiency
- Psychiatric concomitant diseases, which are associated with an altered perception and assessment of pain
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.