Pain, Postoperative
Conditions
Keywords
Serratus Posterior Superior Intercostal Plane Block, Cardiac Implantable Electronic Device, Pain Management, Randomized Controlled Trial
Brief 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.
Detailed description
Cardiac implantable electronic device (CIED) implantation is a common procedure for the management of arrhythmias and prevention of sudden cardiac death. Although routinely performed under local anesthesia, patients may experience intraoperative and postoperative pain, which can affect hemodynamic stability, recovery, and satisfaction. Effective perioperative analgesia is therefore critical in this patient group, who often present with multiple comorbidities and advanced age. Conventional systemic analgesics may be insufficient or associated with side effects, highlighting the need for alternative approaches. The serratus posterior superior intercostal plane block (SPSIPB) is a recently described regional anesthesia technique targeting the interfascial plane between the rhomboid major and serratus posterior superior muscles. Previous studies have shown its efficacy in thoracic, breast, clavicular, and minimally invasive cardiac surgeries. However, its role in the context of CIED implantation has not been systematically studied. This study is designed as a prospective, double-blind, randomized controlled trial. A total of 60 patients scheduled for first-time CIED implantation will be randomized into two groups: the intervention group (SPSIPB with 30 mL 0.25% bupivacaine) and the control group (sham injection with 1 mL saline). All procedures will be performed under standard local anesthesia. The primary outcome is perioperative pain assessed by VAS intraoperatively and at 3, 6, 12, and 24 hours postoperatively. Secondary outcomes include postoperative sleep quality (SQ-NRS) and both patient and clinician satisfaction (5-point Likert scale). The trial will provide evidence regarding the potential of SPSIP block to improve perioperative analgesia and patient-centered outcomes in CIED implantation.
Interventions
PROCEDURESPSIP Block
Ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block performed prior to cardiac implantable electronic device (CIED) implantation. A total of 30 mL of 0.25% bupivacaine will be injected into the interfascial plane between the rhomboid major and serratus posterior superior muscles under sterile conditions.
PROCEDURESham procedure
Sham procedure with 1 mL saline injection at the same anatomical site, without administration of local anesthetic, prior to CIED implantation.
Sponsors
Gozde Altun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants, care providers, and outcome assessors will be blinded to group allocation. The block (bupivacaine or sham saline) will be prepared and administered by an anesthesiologist not involved in outcome assessment.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with local anesthetic or a sham injection with saline. The study is designed as a prospective, double-blind, parallel-group randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Local infection at injection site * Psychiatric or neurologic disorders interfering with pain/sleep assessment * Revision or replacement CIED implantation (not first-time)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity assessed by Visual Analog Scale (VAS) | Intraoperative and postoperative at 3, 6, 12, and 24 hours | Pain levels will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no pain and 10 = worst imaginable pain. Scores will be recorded intraoperatively and at 3h, 6h, 12h, and 24h postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality assessed by Sleep Quality Numeric Rating Scale (SQ-NRS) | 24 hours after surgery | Sleep quality will be measured using the SQ-NRS, scored from 0 = excellent sleep to 10 = worst possible sleep. A score ≥6 indicates poor sleep quality. |
| Patient satisfaction with procedure | 24 hours after surgery | Patients will rate their satisfaction with the procedure on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). |
| Clinician satisfaction with procedure | 24 hours after surgery | Clinicians performing the procedure will rate their satisfaction on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). |
Countries
Turkey (Türkiye)
Contacts
Primary ContactGözde Altun, MD
Backup ContactŞükrü ARSLAN, MD
Outcome results
None listed