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

NCT07697222 | Recruiting FDA Drug FDA Device

• 1 other identifier: 09.2026.769
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pectus Excavatum; Chest Deformities

Keywords

Pectus excavatum; Serratus Anterior Plane Block; Serratus Posterior Superior Intercostal Plane Block; Opioid-Free Anesthesia; Multimodal Analgesia; SAP Block; SPSIP Block; Postoperative Pain; Opioid-Related Adverse Effects; Opioid Consumption; Chest Deformity Surgery; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  From the end of surgery to 24 hours postoperatively

Secondary Outcomes (8)

• Intraoperative opioid consumption

  From induction of anesthesia to the end of surgery

• Postoperative pain scores

  At arrival in the post-anesthesia care unit and at postoperative 6, 12, 24, and 48 hours

• Patient satisfaction

  At postoperative 6, 12, 24, and 48 hours

• Incidence of Opioid-Related Adverse Effects

  From the end of surgery to 48 hours postoperatively

• Duration of anesthesia

  Intraoperative period

Study Arms (2)

Serratus Anterior Plane Block Group

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

Serratus Posterior Superior Intercostal Plane Block Group

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

Interventions

Postoperative Analgesia Protocol DRUG

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.

Serratus Anterior Plane Block Group; Serratus Posterior Superior Intercostal Plane Block Group

Bispectral Index Monitoring DEVICE

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

Serratus Anterior Plane Block Group; Serratus Posterior Superior Intercostal Plane Block Group

Serratus Posterior Superior Intercostal Plane Block PROCEDURE

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

Serratus Posterior Superior Intercostal Plane Block Group

Serratus Anterior Plane Block PROCEDURE

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

Serratus Anterior Plane Block Group

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Istanbul, 34722, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Funnel Chest; Pain, Postoperative

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Cem Özdemir, MD

  Marmara University

  STUDY CHAIR

• Seniyye Ülgen Zengin, Associate Professor, MD

  Marmara University

  PRINCIPAL INVESTIGATOR

• Meliha Orhon Ergün, Associate Professor, MD

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Cem Özdemir, MD

CONTACT

+905385027687; suskungeveze.cem@gmail.com

Seniyye Ülgen Zengin, Associate Professor, MD

CONTACT

+905057142443; ulgen_t@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology, Principal Investigator

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 13, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)