Subcostal TAP Block and EEG Dynamics in Laparoscopic Cholecystectomy

NCT07818954 | Recruiting

• 1 other identifier: TAPEEG-LC-2026-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Intraoperative Nociception; Laparoscopic Cholecystectomy

Keywords

Subcostal TAP Block; Transversus Abdominis Plane Block; Electroencephalography; EEG; Bispectral Index; BIS; Burst Suppression; Intraoperative Analgesia; Multimodal Analgesia; Remifentanil; Nociception; Quality of Recovery

Outcome Measures

Primary Outcomes (4)

• Total Intraoperative Remifentanil Consumption

  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

  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

  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

  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

Secondary Outcomes (7)

• Total Intraoperative Fentanyl Consumption

  From induction of general anesthesia until the end of surgery

• Postoperative Pain at Rest

  At 0, 1, 4, 8, 12, and 24 hours after surgery

• Postoperative Pain During Activity

  At 0, 1, 4, 8, 12, and 24 hours after surgery

• Total Postoperative Rescue Tramadol Consumption

  During the first 24 hours after surgery

• Quality of Recovery-15 Score

  At 24 hours after surgery

Study Arms (2)

Remifentanil Group

Patients receiving intravenous remifentanil infusion without a subcostal TAP block as part of routine perioperative analgesic management during laparoscopic cholecystectomy.

Drug: Remifentanil

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.

Drug: Remifentanil; Procedure: Ultrasound-Guided Subcostal Transversus Abdominis Plane Block

Interventions

Remifentanil DRUG

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

Remifentanil + Subcostal TAP Block Group; Remifentanil Group

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.

Also known as: subcostal TAP Block

Remifentanil + Subcostal TAP Block Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Anders M, Anders B, Dreismickenbecker E, Hight D, Kreuzer M, Walter C, Zinn S. EEG responses to standardised noxious stimulation during clinical anaesthesia: a pilot study. BJA Open. 2022 Dec 30;5:100118. doi: 10.1016/j.bjao.2022.100118. eCollection 2023 Mar.

  PMID: 37587999 RESULT

• MacKay EC, Sleigh JW, Voss LJ, Barnard JP. Episodic waveforms in the electroencephalogram during general anaesthesia: a study of patterns of response to noxious stimuli. Anaesth Intensive Care. 2010 Jan;38(1):102-12. doi: 10.1177/0310057X1003800118.

  PMID: 20191785 RESULT

• Bublitz V, Jurth C, Kreuzer M, Lichtner G, von Dincklage F. Electroencephalogram-based prediction and detection of responsiveness to noxious stimulation in critical care patients: a retrospective single-centre analysis. Br J Anaesth. 2023 Feb;130(2):e339-e350. doi: 10.1016/j.bja.2022.09.031. Epub 2022 Nov 19.

  PMID: 36411130 RESULT

• Garcia PS, Kreuzer M, Hight D, Sleigh JW. Effects of noxious stimulation on the electroencephalogram during general anaesthesia: a narrative review and approach to analgesic titration. Br J Anaesth. 2021 Feb;126(2):445-457. doi: 10.1016/j.bja.2020.10.036.

  PMID: 33461725 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)