An observational study in Pectus Excavatum and Chest Deformities, sponsored by Marmara University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 15 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Marmara University · Observational
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.
Pectus excavatum is the most common chest wall deformity in pediatric and adolescent patients and is characterized by posterior depression of the sternum and anterior chest wall. Although many patients are asymptomatic, corrective surgery is frequently performed during adolescence or young adulthood for cosmetic reasons and to improve body image and quality of life.
Minimally invasive repair of pectus excavatum involves the placement of a curved metal bar beneath the sternum. The bar is then rotated to elevate the sternum and correct the chest wall deformity. Despite favorable cosmetic and quality-of-life outcomes, postoperative pain remains a major clinical challenge after this procedure. Pain is mainly related to sternal elevation, pressure exerted by the bar, and repositioning of the ribs. Inadequate pain control may increase opioid consumption and prolong hospitalization. Higher opioid exposure may also lead to adverse effects such as nausea, vomiting, constipation, pruritus, and urinary retention.
Regional anesthesia techniques have become important components of multimodal postoperative analgesia in thoracic surgery. Thoracic paravertebral block, erector spinae plane block, and serratus anterior plane block are among the regional techniques commonly used for thoracic analgesia. Serratus anterior plane block has also been used for postoperative pain management after minimally invasive repair of pectus excavatum.
Serratus posterior superior intercostal plane block is a recently described ultrasound-guided interfascial plane block. The technique involves injection of local anesthetic between the serratus posterior superior muscle and the rib, usually at the level of the second or third rib. This block has been reported to provide analgesia in various thoracic and scapular pain conditions and has shown promising results in thoracic surgery.
The aim of this study is to compare the postoperative analgesic outcomes of serratus posterior superior intercostal plane block and serratus anterior plane block in patients undergoing minimally invasive repair of pectus excavatum. Because this is an observational study, the choice of regional analgesia technique will not be determined by the study protocol. The block technique will be selected by the attending anesthesiologist according to routine clinical practice. No randomization or protocol-driven assignment will be performed.
The study population will include patients aged 15 to 25 years who are diagnosed with pectus excavatum and scheduled to undergo minimally invasive repair of pectus excavatum under general anesthesia. Patients who receive either bilateral serratus posterior superior intercostal plane block or bilateral serratus anterior plane block as part of routine perioperative analgesic care will be included.
Exclusion Criteria:
Participants in this cohort will receive bilateral ultrasound-guided serratus anterior plane block as part of routine perioperative analgesic care.
Drug: Postoperative Analgesia Protocol · Device: Bispectral Index Monitoring · Procedure: Serratus Anterior Plane Block
Participants in this cohort will receive bilateral ultrasound-guided serratus posterior superior intercostal plane block as part of routine perioperative analgesic care.
Drug: Postoperative Analgesia Protocol · Device: Bispectral Index Monitoring · Procedure: Serratus Posterior Superior Intercostal Plane Block
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.
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.
Also known as: BIS, BIS Monitoring
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.
Also known as: SPSIP Block, SPSIPB
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.
Also known as: SAP Block, SAPB
Total postoperative opioid consumption during the first 24 hours
Total opioid consumption during the first 24 hours after surgery will be recorded and expressed as intravenous morphine equivalents in milligrams.
Time frame: From the end of surgery to 24 hours postoperatively
Intraoperative opioid consumption
Total intraoperative opioid consumption will be recorded.
Time frame: From induction of anesthesia to the end of surgery
Postoperative pain scores
Pain intensity will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Time frame: At arrival in the post-anesthesia care unit and at postoperative 6, 12, 24, and 48 hours
Patient satisfaction
Patient satisfaction with postoperative analgesia will be assessed using a 4-point Likert scale, where 0 indicates very dissatisfied and 3 indicates very satisfied.
Time frame: At postoperative 6, 12, 24, and 48 hours
Incidence of Opioid-Related Adverse Effects
Presence of nausea, vomiting, pruritus, constipation, urinary retention, sedation, and respiratory depression. Adverse effects will be compared among the two groups.
Time frame: From the end of surgery to 48 hours postoperatively
Duration of anesthesia
The total duration of anesthesia will be recorded in minutes.
Time frame: Intraoperative period
Duration of surgery
The total duration of surgery will be recorded in minutes.
Time frame: Intraoperative period
Time to mobilization
The time from the end of surgery to first mobilization will be recorded.
Time frame: From the end of surgery until the first documented ambulation, assessed within the first 48 postoperative hours
Length of hospital stay
The duration of postoperative hospitalization will be recorded.
Time frame: Length of postoperative hospital stay, defined as the time from the end of surgery to hospital discharge, assessed up to 30 days postoperatively
Plan to share: No — Individual participant data (IPD) will not be shared. The study involves clinical information collected under institutional ethical approval, and no consent was obtained for external sharing of identifiable or de-identified participant-level data.
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