Laparoscopic CholecystectomyNCT07818954
Subcostal TAP Block and EEG Dynamics in Laparoscopic Cholecystectomy
An observational study of Laparoscopic Cholecystectomy and Postoperative Pain, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy, Postoperative Pain, Intraoperative Nociception
- What is being tested?
- Remifentanil and Ultrasound-Guided Subcostal Transversus Abdominis Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul
Department of Anesthesiology and Reanimation, MD, +90 216 606 33 00, sancaktepeetikkurul@gmail.com
Ezgi Erdag, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Remifentanil, Ultrasound-Guided Subcostal Transversus Abdominis Plane Block
- Keywords
- Subcostal TAP Block, Transversus Abdominis Plane Block, Electroencephalography, EEG, Bispectral Index, BIS, Burst Suppression, Intraoperative Analgesia, Multimodal Analgesia, Remifentanil, Nociception, Quality of Recovery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Intravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management.
Ultrasound-Guided Subcostal Transversus Abdominis Plane BlockProcedure or surgery
Also called subcostal TAP Block
Ultrasound-guided subcostal transversus abdominis plane block performed as part of routine perioperative analgesic management according to the attending anesthesiologist's clinical decision.
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil Group | Patients receiving intravenous remifentanil infusion without a subcostal TAP block as part of routine perioperative analgesic management during laparoscopic cholecystectomy. Receives: 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. Receives: Drug: Remifentanil; Procedure: Ultrasound-Guided Subcostal Transversus Abdominis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From induction of general anesthesia until the end of surgery
Secondary outcomes (7)
Total Intraoperative Fentanyl Consumption
The total dose of intravenous fentanyl administered during laparoscopic cholecystectomy will be recorded from the anesthesia record and compared between the two observational groups.
Measured: From induction of general anesthesia until the end of surgery
Postoperative Pain at Rest
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.
Measured: At 0, 1, 4, 8, 12, and 24 hours after surgery
Postoperative Pain During Activity
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.
Measured: At 0, 1, 4, 8, 12, and 24 hours after surgery
Total Postoperative Rescue Tramadol Consumption
The total dose of intravenous tramadol administered as rescue analgesia for postoperative pain with an NRS score of 4 or greater will be recorded.
Measured: During the first 24 hours after surgery
Quality of Recovery-15 Score
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.
Measured: At 24 hours after surgery
Time to First Mobilization
The time from completion of surgery to the patient's first postoperative mobilization will be recorded.
Measured: Up to 24 hours after surgery
Length of Hospital Stay
The duration of postoperative hospital stay will be recorded and compared between the two observational groups.
Measured: From completion of surgery until hospital discharge Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start15 Jul 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818954
- Sponsor's protocol ID
- TAPEEG-LC-2026-01
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37587999MacKay 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.
PubMed 20191785Bublitz 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.
PubMed 36411130Garcia 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.
PubMed 33461725
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Subcostal Transversus Abdominis Plane Block on Analgesia, EEG Dynamics, and Burst Suppression in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07818954
- Acronym / sponsor ID
- TAPEEG-LC-2026-01
- Keywords
- Subcostal TAP Block, Transversus Abdominis Plane Block, Electroencephalography, EEG, Bispectral Index, BIS, Burst Suppression, Intraoperative Analgesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil Group | – | Drug: RemifentanilPatients receiving intravenous remifentanil infusion without a subcostal TAP block as part of routine perioperative analgesic management during laparoscopic cholecystectomy. |
| Remifentanil + Subcostal TAP Block Group | – | Drug: Remifentanil, Procedure: Ultrasound-Guided Subcostal Transversus Abdominis Plane BlockPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilIntravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management. | Drug | Remifentanil + Subcostal TAP Block Group, Remifentanil Group |
| Ultrasound-Guided Subcostal Transversus Abdominis Plane BlockAlso: subcostal TAP BlockUltrasound-guided subcostal transversus abdominis plane block performed as part of routine perioperative analgesic management according to the attending anesthesiologist's clinical decision. | Procedure or surgery | Remifentanil + Subcostal TAP Block Group |
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
Total Intraoperative Fentanyl Consumption
Time frame: From induction of general anesthesia until the end of surgery
Postoperative Pain at Rest
Time frame: At 0, 1, 4, 8, 12, and 24 hours after surgery
Postoperative Pain During Activity
Time frame: At 0, 1, 4, 8, 12, and 24 hours after surgery
Total Postoperative Rescue Tramadol Consumption
Time frame: During the first 24 hours after surgery
Quality of Recovery-15 Score
Time frame: At 24 hours after surgery
Time to First Mobilization
Time frame: Up to 24 hours after surgery
Length of Hospital Stay
Time frame: From completion of surgery until hospital discharge Up to 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 37587999Anders 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.
- Results publication: PubMed 20191785MacKay 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.
- Results publication: PubMed 36411130Bublitz 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.
- Results publication: PubMed 33461725Garcia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Cholecystectomy and Postoperative Pain, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Intraoperative Remifentanil Consumption (time frame: From induction of general anesthesia until the end of surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07818954, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.