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Subcostal TAP Block and EEG Dynamics in Laparoscopic Cholecystectomy

11. september 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

60

Kontakter og plasseringer

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

Studiesteder

  • Tyrkia (Türkiye)
      • Istanbul, Tyrkia (Türkiye)
        • Rekruttering
        • Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
        • Ta kontakt med:
        • Ta kontakt med:
          • Ezgi Erdag, MD
        • Hovedetterforsker:
          • Nurten Bakan

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Remifentanil Group
Patients receiving intravenous remifentanil infusion without a subcostal TAP block as part of routine perioperative analgesic management during laparoscopic cholecystectomy.
Legemiddel: 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.
Legemiddel: Remifentanil
Intravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management.
Fremgangsmåte: 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.
Andre navn:
  • subcostal TAP Block

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total Intraoperative Remifentanil Consumption
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total Intraoperative Fentanyl Consumption
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

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

Sponsor

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 (Faktiske)

15. juli 2026

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

8. september 2026

Først innsendt som oppfylte QC-kriteriene

11. september 2026

Først lagt ut (Faktiske)

14. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TAPEEG-LC-2026-01

Plan for individuelle deltakerdata (IPD)

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NEI

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Nei

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Nei

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