Serratus Posterior Superior Intercostal Plane Block in Cardiac Implantable Electronic Device Impl… (NCT07165041) | Clinical Trial Compass
CompletedNot Applicable
Serratus Posterior Superior Intercostal Plane Block in Cardiac Implantable Electronic Device Implantation
Turkey (Türkiye)60 participantsStarted 2025-06-30
Plain-language summary
This randomized controlled clinical trial investigates the efficacy of the serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing cardiac implantable electronic device (CIED) implantation. Participants will be randomized to receive either SPSIP block with local anesthetic or a sham procedure with saline injection. Pain intensity will be evaluated intraoperatively and at 3, 6, 12, and 24 hours postoperatively using the Visual Analog Scale (VAS). Secondary outcomes include sleep quality at 24 hours assessed with the Sleep Quality Numeric Rating Scale (SQ-NRS), and patient and clinician satisfaction assessed with a 5-point Likert scale. The study is designed as prospective, double-blind, and parallel-group, aiming to improve perioperative pain management in CIED procedures.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults ≥18 years of age
* Scheduled for first-time cardiac implantable electronic device (CIED) implantation (pacemaker or ICD)
* Able to provide written informed consent
* Normal coagulation profile
* No local infection at the planned block site
Exclusion Criteria:
* Severe heart failure (NYHA class IV)
* Morbid obesity (BMI \>35 kg/m²)
* Known allergy to local anesthetics (e.g., bupivacaine)
* Coagulopathy or ongoing anticoagulant therapy contraindicating regional block
* An established history of chronic pain, or diagnosed sleep disorders requiring active treatment (e.g., obstructive sleep apnea syndrome, insomnia)
* Local infection at injection site
* Psychiatric or neurologic disorders interfering with pain/sleep assessment
* Revision or replacement CIED implantation (not first-time)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a specific nerve block called the Serratus Posterior Superior Intercostal Plane Block during cardiac device implantation — is that a technique my surgical team has experience with, and could it be an option for managing my pain after my procedure?
2Since this trial has already been completed and was measuring postoperative pain using a Visual Analog Scale, have the results been published yet, and what did they find about how well this block actually reduced pain compared to standard pain management?
3This trial was categorized as 'Phase NA,' which typically means it's testing a procedure or technique rather than a drug — does that mean the safety profile is better understood than an early-phase drug trial, and what risks are still worth discussing for this specific block?
4If my doctor thinks this nerve block approach showed promise in the trial, what would pain management during and after my cardiac device implantation look like in practice — would it replace other pain medications or be used alongside them?
5Are there standard pain management options already available for cardiac device implantation that I should compare against what this trial was studying, so I can better understand whether this newer technique would offer a meaningful benefit for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative pain intensity assessed by Visual Analog Scale (VAS)
Timeframe: Intraoperative and postoperative at 3, 6, 12, and 24 hours