Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Subcostal TAP Block and EEG Dynamics in Laparoscopic Cholecystectomy

11. září 2026 aktualizováno: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Effect of Subcostal Transversus Abdominis Plane Block on Analgesia, EEG Dynamics, and Burst Suppression in Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is a commonly performed minimally invasive surgical procedure. Despite its minimally invasive nature, surgical stimulation and pneumoperitoneum may cause pain-related physiological and neurophysiological responses during general anesthesia.

This prospective observational study will evaluate patients undergoing laparoscopic cholecystectomy under general anesthesia. Patients will be observed according to the analgesic technique selected by the attending anesthesiologist as part of routine clinical care: intravenous remifentanil alone or remifentanil combined with an ultrasound-guided subcostal transversus abdominis plane (TAP) block.

The study will examine the relationship between the use of subcostal TAP block and intraoperative analgesic requirements, Bispectral Index (BIS) values, electroencephalographic (EEG) dynamics, and burst suppression. Postoperative pain scores, additional analgesic requirements, quality of recovery, mobilization time, length of hospital stay, and patient satisfaction will also be evaluated.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

This is a prospective, single-center observational study including adult patients scheduled for laparoscopic cholecystectomy under general anesthesia. The study will be conducted at Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital.

Perioperative analgesic management will be determined by the attending anesthesiologist according to routine clinical practice and will not be assigned by the study protocol. Patients will subsequently be evaluated in two observational groups according to the analgesic technique received. One group will consist of patients receiving intravenous remifentanil infusion without a subcostal TAP block, while the other group will consist of patients receiving intravenous remifentanil infusion together with an ultrasound-guided subcostal TAP block.

General anesthesia will be maintained using sevoflurane and remifentanil according to routine clinical practice. Depth of anesthesia and cerebral electrical activity will be monitored using Bispectral Index (BIS) monitoring and electroencephalography (EEG). Intraoperative EEG characteristics, including changes in alpha-band activity and burst suppression, as well as BIS values, will be recorded and compared between the two groups.

Intraoperative analgesic consumption, including remifentanil and additional fentanyl use, will be recorded from anesthesia records. Hemodynamic responses and other routinely monitored parameters will also be documented.

Postoperative pain will be evaluated using the Numerical Rating Scale (NRS) at rest and during activity at 0, 1, 4, 8, 12, and 24 hours after surgery. Routine postoperative analgesia includes intravenous paracetamol and tenoxicam. When clinically indicated for inadequate pain control, rescue analgesia with intravenous tramadol may be administered according to routine clinical practice, and additional analgesic consumption will be recorded.

Postoperative recovery will additionally be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). Mobilization time, length of hospital stay, and patient satisfaction will also be recorded.

The primary objective of the study is to evaluate the association between subcostal TAP block use and intraoperative analgesic requirements, anesthetic depth, EEG dynamics, and burst suppression. Secondary objectives include comparison of postoperative pain, additional analgesic consumption, quality of recovery, mobilization time, length of hospital stay, and patient satisfaction between the two groups.

Typ studie

Pozorovací

Zápis (Odhadovaný)

60

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Turecko (Türkiye)
      • Istanbul, Turecko (Türkiye)
        • Nábor
        • Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
        • Kontakt:
        • Kontakt:
          • Ezgi Erdag, MD
        • Vrchní vyšetřovatel:
          • Nurten Bakan

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Adult patients aged 18 years or older with ASA physical status I-III who are scheduled to undergo laparoscopic cholecystectomy under general anesthesia at Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital and who provide written informed consent will be included. Patients will be evaluated according to the perioperative analgesic technique selected by the attending anesthesiologist as part of routine clinical care.

Popis

Inclusion Criteria:

  • Age 18 years or older
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled to undergo laparoscopic cholecystectomy under general anesthesia
  • Written informed consent provided by the participant or, when applicable, the legally authorized representative

Exclusion Criteria:

  • Refusal to participate in the study
  • American Society of Anesthesiologists (ASA) physical status IV-V
  • Known allergy or hypersensitivity to medications used during perioperative anesthetic or analgesic management

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Remifentanil Group
Patients receiving intravenous remifentanil infusion without a subcostal TAP block as part of routine perioperative analgesic management during laparoscopic cholecystectomy.
Lék: Remifentanil
Intravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management.
Remifentanil + Subcostal TAP Block Group
Patients receiving intravenous remifentanil infusion together with an ultrasound-guided subcostal transversus abdominis plane (TAP) block as part of routine perioperative analgesic management during laparoscopic cholecystectomy.
Lék: Remifentanil
Intravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management.
Postup: Ultrasound-Guided Subcostal Transversus Abdominis Plane Block
Ultrasound-guided subcostal transversus abdominis plane block performed as part of routine perioperative analgesic management according to the attending anesthesiologist's clinical decision.
Ostatní jména:
  • subcostal TAP Block

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Total Intraoperative Remifentanil Consumption
Časové okno: From induction of general anesthesia until the end of surgery
Total amount of intravenous remifentanil administered during laparoscopic cholecystectomy will be recorded from the anesthesia record and compared between the remifentanil-only group and the remifentanil plus subcostal TAP block group.
From induction of general anesthesia until the end of surgery
Intraoperative Bispectral Index Values
Časové okno: From induction of general anesthesia until the end of surgery
Bispectral Index (BIS) values recorded during general anesthesia will be evaluated to assess anesthetic depth and compared between the two observational groups.
From induction of general anesthesia until the end of surgery
Intraoperative EEG Alpha-Band Activity
Časové okno: From induction of general anesthesia until the end of surgery
Changes in electroencephalographic alpha-band activity during general anesthesia and surgical stimulation will be recorded and compared between the two observational groups.
From induction of general anesthesia until the end of surgery
Intraoperative Burst Suppression
Časové okno: From induction of general anesthesia until the end of surgery
Burst suppression observed on intraoperative EEG monitoring during general anesthesia will be recorded and compared between the two observational groups.
From induction of general anesthesia until the end of surgery

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Total Intraoperative Fentanyl Consumption
Časové okno: From induction of general anesthesia until the end of surgery
The total dose of intravenous fentanyl administered during laparoscopic cholecystectomy will be recorded from the anesthesia record and compared between the two observational groups.
From induction of general anesthesia until the end of surgery
Postoperative Pain at Rest
Časové okno: At 0, 1, 4, 8, 12, and 24 hours after surgery
Pain intensity at rest will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Measurements will be recorded at 0, 1, 4, 8, 12, and 24 hours after surgery.
At 0, 1, 4, 8, 12, and 24 hours after surgery
Postoperative Pain During Activity
Časové okno: At 0, 1, 4, 8, 12, and 24 hours after surgery
Pain intensity during activity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Measurements will be recorded at 0, 1, 4, 8, 12, and 24 hours after surgery.
At 0, 1, 4, 8, 12, and 24 hours after surgery
Total Postoperative Rescue Tramadol Consumption
Časové okno: During the first 24 hours after surgery
The total dose of intravenous tramadol administered as rescue analgesia for postoperative pain with an NRS score of 4 or greater will be recorded.
During the first 24 hours after surgery
Quality of Recovery-15 Score
Časové okno: At 24 hours after surgery
Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
At 24 hours after surgery
Time to First Mobilization
Časové okno: Up to 24 hours after surgery
The time from completion of surgery to the patient's first postoperative mobilization will be recorded.
Up to 24 hours after surgery
Length of Hospital Stay
Časové okno: From completion of surgery until hospital discharge Up to 7 days
The duration of postoperative hospital stay will be recorded and compared between the two observational groups.
From completion of surgery until hospital discharge Up to 7 days

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. července 2026

Primární dokončení (Odhadovaný)

31. prosince 2026

Dokončení studie (Odhadovaný)

31. prosince 2026

Termíny zápisu do studia

První předloženo

8. září 2026

První předloženo, které splnilo kritéria kontroly kvality

11. září 2026

První zveřejněno (Aktuální)

14. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • TAPEEG-LC-2026-01

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit