- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07801794
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
Status
Bedingungen
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
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Fikret Salik, MD
- Telefonnummer: +905076214125
- E-Mail: fikretsalik@gmail.com
Studienorte
-
-
Diyarbakır
-
Diyarbakır, Diyarbakır, Türkei (türkiye)
- Dicle University Faculty of Medicine Hospital
-
Kontakt:
- Fikret Salik, MD
- Telefonnummer: +90 507 621 4125
- E-Mail: fikretsalik@gmail.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
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
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
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 398
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .