SPSIPB Versus SAPB for Postoperative Analgesia After Minimally Invasive Repair of Pectus Excavatum

NCT07697222 · tracked via the Priya Life Science Turkey tracker

Sponsor

Marmara University

Phase

Observational

Started

2026-06-22

Last updated

2026-07-13

Condition(s) studied

Pectus ExcavatumChest Deformities

Investigational drug(s) / intervention(s)

Postoperative Analgesia ProtocolBispectral Index MonitoringSerratus Posterior Superior Intercostal Plane BlockSerratus Anterior Plane Block

Postoperative Analgesia Protocol: All participants will receive a standardized multimodal postoperative analgesia protocol. Patient-controlled analgesia with intravenous morphine will be used. The device will be programmed to administer 1 mg of intravenous morphine per demand, with a lockout interval of 10 minutes. Paracetamol will be administered as part of routine multimodal analgesia. If adequate analgesia cannot be achieved, 100 mg tramadol will be administered as rescue analgesia according to clinical need.

Bispectral Index Monitoring: Continuous intraoperative depth of anesthesia monitoring using the Bispectral Index (BIS) device. BIS values are recorded throughout the procedure to assist in titration of anesthetic agents and to standardize anesthesia depth across study cohorts. The BIS device is used for monitoring only, and no device-related investigational procedures are performed.

Serratus Posterior Superior Intercostal Plane Block: Bilateral ultrasound-guided serratus posterior superior intercostal plane block will be performed according to standard techniques described in the literature and routinely used in the clinic. Local anesthetic dosing will be determined according to institutional practice and safety limits. In bilateral applications, the total bupivacaine dose will not exceed 2.5 mg/kg.

Serratus Anterior Plane Block: Bilateral ultrasound-guided serratus anterior plane block will be performed according to standard techniques described in the literature and routinely used in the clinic. Local anesthetic dosing will be determined according to institutional practice and safety limits. In bilateral applications, the total bupivacaine dose will not exceed 2.5 mg/kg.

Study summary

This prospective observational cohort study will compare postoperative analgesic outcomes in patients undergoing minimally invasive repair of pectus excavatum. Participants will be grouped according to the regional analgesia technique applied as part of routine clinical care: serratus posterior superior intercostal plane block or serratus anterior plane block. The primary outcome will be total opioid consumption during the first 24 hours after surgery. Secondary outcomes will include postoperative pain scores, rescue analgesic requirement, opioid-related adverse effects, patient satisfaction, mobilization time, and length of hospital stay.

Eligibility

Sex

ALL

Min age

15 Years

Max age

25 Years

Healthy volunteers

Inclusion Criteria: * Patients aged 15 to 25 years * Diagnosis of pectus excavatum * Scheduled to undergo minimally invasive repair of pectus excavatum under general anesthesia * Receipt of either bilateral serratus posterior superior intercostal plane block or bilateral serratus anterior plane block as part of routine perioperative analgesic care * Written informed consent obtained from the patient or, for patients younger than 18 years, from a legal guardian Exclusion Criteria: * Refusal to participate in the study * Contraindication to regional anesthesia * Known allergy to local anesthetics or study analgesic medications * Chronic opioid use * Pre-existing chronic pain syndrome * Coagulopathy or use of anticoagulant therapy that contraindicates regional block application * Local infection at the block injection site * Neurological or psychiatric condition that may interfere with pain assessment * Incomplete perioperative or postoperative data * Conversion to another surgical technique or major intraoperative complication requiring a change in the routine analgesic protocol

Primary outcome measure(s)

Total postoperative opioid consumption during the first 24 hours — From the end of surgery to 24 hours postoperatively
Total opioid consumption during the first 24 hours after surgery will be recorded and expressed as intravenous morphine equivalents in milligrams.

Trial sites (1)

Facility	City	Region	Status
Marmara University	Istanbul	Istanbul	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07697222 on ClinicalTrials.gov ↗ ← All trials in Turkey