Subcostal TAP Block and EEG Dynamics in Laparoscopic Cholecystectomy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Remifentanil
DrugIntravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management.
Ultrasound-Guided Subcostal Transversus Abdominis Plane Block
Procedure/SurgeryUltrasound-guided subcostal transversus abdominis plane block performed as part of routine perioperative analgesic management according to the attending anesthesiologist's clinical decision.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Remifentanil Group1 intervention
Group B: Remifentanil + Subcostal TAP Block Group2 interventions
Trial outcomes
Primary outcomes
1
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 surgery2
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 surgery3
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 surgery4
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 surgerySecondary outcomes
1
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 surgery2
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 surgery3
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 surgery4
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 surgerySponsors and contacts
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Source ClinicalTrials.gov