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NCT Number: NCT07818954

Subcostal TAP Block and EEG Dynamics 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Department of Anesthesiology and Reanimation, MD

CONTACT

[email protected]

+90 216 606 33 00

Ezgi Erdag, MD

CONTACT

Nurten Bakan

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

Intravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management.

Ultrasound-Guided Subcostal Transversus Abdominis Plane Block

Procedure

Ultrasound-guided subcostal transversus abdominis plane block performed as part of routine perioperative analgesic management according to the attending anesthesiologist's clinical decision.

Other names: subcostal TAP Block

Primary outcomes

  1. Total Intraoperative Remifentanil Consumption

    Time frame: 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.

  2. Intraoperative Bispectral Index Values

    Time frame: 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.

  3. Intraoperative EEG Alpha-Band Activity

    Time frame: 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.

  4. Intraoperative Burst Suppression

    Time frame: 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.

Secondary outcomes

  1. Total Intraoperative Fentanyl Consumption

    Time frame: 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.

  2. Postoperative Pain at Rest

    Time frame: 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.

  3. Postoperative Pain During Activity

    Time frame: 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.

  4. Total Postoperative Rescue Tramadol Consumption

    Time frame: 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.

  5. Quality of Recovery-15 Score

    Time frame: 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.

  6. Time to First Mobilization

    Time frame: Up to 24 hours after surgery

    The time from completion of surgery to the patient's first postoperative mobilization will be recorded.

  7. Length of Hospital Stay

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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