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Comparison of TAP Block and Umbilical Paramedian Linea Semilunaris Block in Pediatric Laparoscopic Surgery

Comparison of Transversus Abdominis Plane Block and Umbilical Paramedian Linea Semilunaris Block in Pediatric Laparoscopic Surgery: A Prospective Randomized Controlled Trial

The aim of this prospective randomized controlled trial is to compare the postoperative analgesic efficacy of ultrasound-guided transversus abdominis plane (TAP) block and umbilical paramedian linea semilunaris block in pediatric patients undergoing elective laparoscopic abdominal surgery.

A total of 56 pediatric patients will be randomly assigned in a 1:1 ratio to receive either a TAP block or a linea semilunaris block after induction of general anesthesia and before the start of surgery. Both blocks will be performed under ultrasound guidance using 0.2% bupivacaine at a volume of 0.5 mL/kg, with the total dose limited to 2 mg/kg.

The primary outcome will be total opioid consumption during the first 24 hours after surgery. Secondary outcomes will include postoperative pain scores, time to first analgesic requirement, additional analgesic requirements, postoperative nausea and vomiting, and block-related complications.

Studienübersicht

Detaillierte Beschreibung

Effective postoperative pain management is an important component of perioperative care in pediatric patients. Inadequately controlled postoperative pain may result in agitation, delayed mobilization, delayed oral intake, prolonged hospitalization, and increased analgesic requirements. Although opioids are commonly used for postoperative analgesia, their use in pediatric patients may be associated with adverse effects such as nausea, vomiting, sedation, respiratory depression, and delayed recovery. Therefore, opioid-sparing multimodal analgesic strategies, including ultrasound-guided regional anesthesia techniques, have become increasingly important in pediatric perioperative care.

The transversus abdominis plane (TAP) block is one of the commonly used abdominal wall blocks in pediatric abdominal surgery. However, its dermatomal distribution may be variable, and adequate analgesia may require bilateral or multiple injections. The linea semilunaris block is a more recently described fascial plane block targeting the anatomical region where the internal oblique and transversus abdominis muscles converge. This approach may allow wider local anesthetic spread and potentially provide effective analgesia for both the lateral abdominal wall and regions closer to the midline. However, clinical evidence regarding the linea semilunaris block remains limited, particularly in pediatric patients.

This prospective, randomized controlled trial will include 56 pediatric patients undergoing elective laparoscopic abdominal surgery. After written informed consent is obtained from a parent or legal guardian, participants will be randomly assigned in a 1:1 ratio using a computer-generated randomization sequence and sequentially numbered, sealed, opaque envelopes.

Following induction of general anesthesia and before the start of surgery, participants will receive one of two ultrasound-guided regional anesthesia techniques. Participants assigned to the linea semilunaris block group will receive an ultrasound-guided linea semilunaris block, whereas participants assigned to the TAP block group will receive an ultrasound-guided transversus abdominis plane block. In both groups, 0.2% bupivacaine will be administered at a volume of 0.5 mL/kg, with the total bupivacaine dose limited to 2 mg/kg. All block procedures will be performed by anesthesiologists experienced in pediatric ultrasound-guided regional anesthesia.

All participants will receive standard general anesthesia and perioperative monitoring. Postoperative pain will be assessed using age-appropriate FLACC or Wong-Baker Faces pain scales at predefined postoperative time points.

The primary outcome of the study will be total opioid consumption during the first 24 hours after surgery. Secondary outcomes will include postoperative pain scores, time to first analgesic requirement, additional analgesic requirements, postoperative nausea and vomiting, and block-related complications. The study aims to determine whether the linea semilunaris block provides effective postoperative analgesia and reduces opioid requirements compared with the TAP block in pediatric laparoscopic abdominal surgery.

Studientyp

Interventionell

Einschreibung (Geschätzt)

56

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • Diyarbakır
      • Diyarbakır, Diyarbakır, Türkei (türkiye)
        • Dicle University Faculty of Medicine Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Patients scheduled for elective pediatric laparoscopic abdominal surgery
  • Age within the specified eligibility range
  • American Society of Anesthesiologists (ASA) physical status I or II
  • Written informed consent provided by a parent or legal guardian
  • Adequate ultrasound visualization for the planned regional block
  • No known allergy to bupivacaine or ultrasound gel
  • No coagulopathy
  • No infection at the block injection site
  • No previous surgery at the block injection site
  • No anticipated requirement for postoperative intensive care unit admission

Exclusion Criteria:

  • Refusal of the parent or legal guardian to participate
  • Emergency surgery
  • Inadequate ultrasound visualization
  • Coagulopathy
  • Infection or previous surgery at the block injection site
  • Known allergy to bupivacaine or ultrasound gel
  • Conversion from laparoscopic to open surgery
  • Requirement for postoperative intensive care unit admission
  • ASA physical status III or higher

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: USG Guided Transversus Abdominis Plane Block
Participants randomized to this group will receive an ultrasound-guided transversus abdominis plane (TAP) block after induction of general anesthesia and before the start of surgery. The block will be performed using 0.2% bupivacaine at a volume of 0.5 mL/kg, with the total bupivacaine dose limited to 2 mg/kg.
Following induction of general anesthesia and before the start of surgery, an ultrasound-guided transversus abdominis plane (TAP) block will be performed. After identification of the target fascial plane and confirmation by hydrodissection, 0.2% bupivacaine will be administered at a volume of 0.5 mL/kg. The total bupivacaine dose will be limited to 2 mg/kg.
Experimental: USG Guided Linea Semlunaris Block
Participants randomized to this group will receive an ultrasound-guided umbilical paramedian linea semilunaris block after induction of general anesthesia and before the start of surgery. After identification of the linea semilunaris and confirmation of the target plane by hydrodissection, 0.2% bupivacaine will be administered at a volume of 0.5 mL/kg, with the total bupivacaine dose limited to 2 mg/kg.
Following induction of general anesthesia and before the start of surgery, an ultrasound-guided umbilical paramedian linea semilunaris block will be performed. The linea semilunaris will be identified under ultrasound guidance, and the appropriate fascial plane will be confirmed by hydrodissection. Subsequently, 0.2% bupivacaine will be administered at a volume of 0.5 mL/kg. The total bupivacaine dose will be limited to 2 mg/kg.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total Postoperative Opioid Consumption During the First 24 Hours
Zeitfenster: First 24 hours after surgery
Total opioid consumption administered for postoperative analgesia will be recorded during the first 24 hours after surgery.
First 24 hours after surgery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Postoperative Pain Scores
Zeitfenster: At 0 and 30 minutes, and 4, 8, 12, and 24 hours postoperatively
Postoperative pain intensity will be assessed using age-appropriate pain assessment scales (FLACC or Wong-Baker Faces Pain Rating Scale).
At 0 and 30 minutes, and 4, 8, 12, and 24 hours postoperatively

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

25. August 2026

Primärer Abschluss (Geschätzt)

15. Dezember 2026

Studienabschluss (Geschätzt)

31. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

31. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. August 2026

Zuerst gepostet (Tatsächlich)

3. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data (IPD) will not be shared.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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