Gozde Altun
Istanbul, 34098, Turkey (Türkiye)
NCT Number: NCT07165041
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Istanbul, 34098, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Sham procedure with 1 mL saline injection at the same anatomical site, without administration of local anesthetic, prior to CIED implantation.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours after surgery
Patients will rate their satisfaction with the procedure on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
Time frame: 24 hours after surgery
Clinicians performing the procedure will rate their satisfaction on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
Gozde Altun
Other
Efficacy of Serratus Posterior Superior Intercostal Plane Block in Cardiac Implantable Electronic Device Implantation: A Prospective, Double-Blind, Randomized Controlled Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06282666
Acute Pain, Agnosia
Lublin, Poland
View Trial DetailsNCT04624880
Agnosia, Disease Attributes
Palo Alto, California, United States
View Trial DetailsNCT06217263
Agnosia, Chest Tubes
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07442123
Agnosia, Arthropathy of Knee
Ankara, Turkey (Türkiye)
View Trial Details