Subcostal TAP Block and EEG Dynamics in Laparoscopic Cholecystectomy
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Recruiting
- Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
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Contact:
- Department of Anesthesiology and Reanimation, MD
- Phone Number: +90 216 606 33 00
- Email: sancaktepeetikkurul@gmail.com
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Contact:
- Ezgi Erdag, MD
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Principal Investigator:
- Nurten Bakan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Remifentanil Group
Patients receiving intravenous remifentanil infusion without a subcostal TAP block as part of routine perioperative analgesic management during laparoscopic cholecystectomy.
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Intravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management.
|
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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.
|
Intravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management.
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total Intraoperative Remifentanil Consumption
Time Frame: From induction of general anesthesia until the end of surgery
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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.
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From induction of general anesthesia until the end of surgery
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Intraoperative Bispectral Index Values
Time Frame: From induction of general anesthesia until the end of surgery
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Bispectral Index (BIS) values recorded during general anesthesia will be evaluated to assess anesthetic depth and compared between the two observational groups.
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From induction of general anesthesia until the end of surgery
|
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Intraoperative EEG Alpha-Band Activity
Time Frame: From induction of general anesthesia until the end of surgery
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Changes in electroencephalographic alpha-band activity during general anesthesia and surgical stimulation will be recorded and compared between the two observational groups.
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From induction of general anesthesia until the end of surgery
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Intraoperative Burst Suppression
Time Frame: From induction of general anesthesia until the end of surgery
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Burst suppression observed on intraoperative EEG monitoring during general anesthesia will be recorded and compared between the two observational groups.
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From induction of general anesthesia until the end of surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total Intraoperative Fentanyl Consumption
Time Frame: From induction of general anesthesia until the end of surgery
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The total dose of intravenous fentanyl administered during laparoscopic cholecystectomy will be recorded from the anesthesia record and compared between the two observational groups.
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From induction of general anesthesia until the end of surgery
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Postoperative Pain at Rest
Time Frame: At 0, 1, 4, 8, 12, and 24 hours after surgery
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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.
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At 0, 1, 4, 8, 12, and 24 hours after surgery
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Postoperative Pain During Activity
Time Frame: At 0, 1, 4, 8, 12, and 24 hours after surgery
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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.
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At 0, 1, 4, 8, 12, and 24 hours after surgery
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Total Postoperative Rescue Tramadol Consumption
Time Frame: During the first 24 hours after surgery
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The total dose of intravenous tramadol administered as rescue analgesia for postoperative pain with an NRS score of 4 or greater will be recorded.
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During the first 24 hours after surgery
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Quality of Recovery-15 Score
Time Frame: At 24 hours after surgery
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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.
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At 24 hours after surgery
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Time to First Mobilization
Time Frame: Up to 24 hours after surgery
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The time from completion of surgery to the patient's first postoperative mobilization will be recorded.
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Up to 24 hours after surgery
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Length of Hospital Stay
Time Frame: From completion of surgery until hospital discharge Up to 7 days
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The duration of postoperative hospital stay will be recorded and compared between the two observational groups.
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From completion of surgery until hospital discharge Up to 7 days
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Acids, Acyclic
- Carboxylic Acids
- Piperidines
- Propionates
- Remifentanil
Other Study ID Numbers
- TAPEEG-LC-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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