- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Fikret Salik, MD
- Numer telefonu: +905076214125
- E-mail: fikretsalik@gmail.com
Lokalizacje studiów
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Diyarbakır
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Diyarbakır, Diyarbakır, Turcja (Türkiye)
- Dicle University Faculty of Medicine Hospital
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Kontakt:
- Fikret Salik, MD
- Numer telefonu: +90 507 621 4125
- E-mail: fikretsalik@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny 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.
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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.
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Eksperymentalny: 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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Total Postoperative Opioid Consumption During the First 24 Hours
Ramy czasowe: First 24 hours after surgery
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Total opioid consumption administered for postoperative analgesia will be recorded during the first 24 hours after surgery.
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First 24 hours after surgery
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Postoperative Pain Scores
Ramy czasowe: At 0 and 30 minutes, and 4, 8, 12, and 24 hours postoperatively
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Postoperative pain intensity will be assessed using age-appropriate pain assessment scales (FLACC or Wong-Baker Faces Pain Rating Scale).
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At 0 and 30 minutes, and 4, 8, 12, and 24 hours postoperatively
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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 398
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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