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

6 juli 2026 uppdaterad av: Ulgen Zengin, Marmara University

Comparison of the Postoperative Analgesic Effects of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block After Minimally Invasive Repair of Pectus Excavatum: A Prospective Observational Cohort Study

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

80

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Seniyye Ülgen Zengin, Associate Professor, MD
  • Telefonnummer: +905057142443
  • E-post: ulgen_t@yahoo.com

Studieorter

  • Turkiet (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkiet (Türkiye), 34722
        • Rekrytering
        • Marmara University
        • Kontakt:
        • Kontakt:
          • Seniyye Ülgen Zengin, Associate Professor, MD
          • Telefonnummer: +905057142443
          • E-post: ulgen_t@yahoo.com
        • Huvudutredare:
          • Seniyye Ülgen Zengin, Associate Professor, MD
        • Underutredare:
          • Cem Özdemir, MD
        • Underutredare:
          • Meliha Orhon Ergün, Associate Professor, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Enhet: Bispectral Index Monitoring
Kontinuerlig intraoperativ övervakning av anestesidjup med Bispectral Index (BIS)-enheten. BIS-värden registreras under hela ingreppet för att underlätta titrering av anestesimedel och för att standardisera anestesidjupet mellan studiekohorterna. BIS-enheten används endast för övervakning, och inga enhetsrelaterade undersökningsprocedurer utförs.
Andra namn:
  • BIS-övervakning
  • BIS
Läkemedel: 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.
Procedur: 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.
Andra namn:
  • SAPB
  • SAP-blockering
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.
Enhet: Bispectral Index Monitoring
Kontinuerlig intraoperativ övervakning av anestesidjup med Bispectral Index (BIS)-enheten. BIS-värden registreras under hela ingreppet för att underlätta titrering av anestesimedel och för att standardisera anestesidjupet mellan studiekohorterna. BIS-enheten används endast för övervakning, och inga enhetsrelaterade undersökningsprocedurer utförs.
Andra namn:
  • BIS-övervakning
  • BIS
Läkemedel: 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.
Procedur: 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.
Andra namn:
  • SPSIPB
  • SPSIP-block

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Total postoperative opioid consumption during the first 24 hours
Tidsram: 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.
From the end of surgery to 24 hours postoperatively

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Intraoperative opioid consumption
Tidsram: From induction of anesthesia to the end of surgery
Total intraoperative opioid consumption will be recorded.
From induction of anesthesia to the end of surgery
Postoperative pain scores
Tidsram: At arrival in the post-anesthesia care unit and at postoperative 6, 12, 24, and 48 hours
Pain intensity will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
At arrival in the post-anesthesia care unit and at postoperative 6, 12, 24, and 48 hours
Patient satisfaction
Tidsram: At postoperative 6, 12, 24, and 48 hours
Patient satisfaction with postoperative analgesia will be assessed using a 4-point Likert scale, where 0 indicates very dissatisfied and 3 indicates very satisfied.
At postoperative 6, 12, 24, and 48 hours
Incidence of Opioid-Related Adverse Effects
Tidsram: From the end of surgery to 48 hours postoperatively
Presence of nausea, vomiting, pruritus, constipation, urinary retention, sedation, and respiratory depression. Adverse effects will be compared among the two groups.
From the end of surgery to 48 hours postoperatively
Duration of anesthesia
Tidsram: Intraoperative period
The total duration of anesthesia will be recorded in minutes.
Intraoperative period
Duration of surgery
Tidsram: Intraoperative period
The total duration of surgery will be recorded in minutes.
Intraoperative period
Time to mobilization
Tidsram: From the end of surgery until the first documented ambulation, assessed within the first 48 postoperative hours
The time from the end of surgery to first mobilization will be recorded.
From the end of surgery until the first documented ambulation, assessed within the first 48 postoperative hours
Length of hospital stay
Tidsram: Length of postoperative hospital stay, defined as the time from the end of surgery to hospital discharge, assessed up to 30 days postoperatively
The duration of postoperative hospitalization will be recorded.
Length of postoperative hospital stay, defined as the time from the end of surgery to hospital discharge, assessed up to 30 days postoperatively

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Marmara University

Utredare

  • Studiestol: Cem Özdemir, MD, Marmara University
  • Huvudutredare: Seniyye Ülgen Zengin, Associate Professor, MD, Marmara University
  • Studierektor: Meliha Orhon Ergün, Associate Professor, MD, Marmara University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

22 juni 2026

Primärt slutförande (Beräknad)

1 juni 2027

Avslutad studie (Beräknad)

1 juni 2027

Studieregistreringsdatum

Först inskickad

30 juni 2026

Först inskickad som uppfyllde QC-kriterierna

6 juli 2026

Första postat (Faktisk)

13 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 09.2026.769

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Ja

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