An observational study in Laparoscopic Cholecystectomy, Postoperative Pain and Intraoperative Nociception, sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Observational
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 60 is below the median of 102 across 683 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital is the lead sponsor of 41 studies on the registry; 14 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receiving intravenous remifentanil infusion without a subcostal TAP block as part of routine perioperative analgesic management during laparoscopic cholecystectomy.
Drug: Remifentanil
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
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.
Also known as: subcostal TAP Block
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From induction of general anesthesia until the end of surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From completion of surgery until hospital discharge Up to 7 days
Plan to share: No
Started Jul 2026 (actual). Primary completion is estimated for Dec 2026, 5 months after the start.
Of 391 non-industry observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 5 months is below that.
Counting every sponsor, half of 395 studies reached it within 13 months; a quarter within 5 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital