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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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

56

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Diyarbakır
      • Diyarbakır, Diyarbakır, Tyrkia (Türkiye)
        • Dicle University Faculty of Medicine Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv 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.
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total Postoperative Opioid Consumption During the First 24 Hours
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative Pain Scores
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

25. august 2026

Primær fullføring (Antatt)

15. desember 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

31. august 2026

Først innsendt som oppfylte QC-kriteriene

31. august 2026

Først lagt ut (Faktiske)

3. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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