About this trial
This prospective observational study is designed to evaluate the effects of modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and external oblique intercostal (EOI) plane block on intraoperative analgesia and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. Abdominal wall blocks are widely used to improve perioperative analgesia; however, their impact on intraoperative opioid requirements when guided by objective nociception monitoring remains unclear.
All patients will receive standardized general anesthesia. Intraoperative analgesia will be guided using the Skin Conductance Algesimeter (SCA), which reflects sympathetic nervous system activity by measuring fluctuations in skin conductance. The SCA parameter "peaks per second (PPS)" will be used to assess nociceptive responses. Remifentanil infusion will be titrated according to SCA values to maintain adequate analgesia. Dose adjustments will be performed at predefined intervals, and changes will be considered valid only if sustained for a minimum duration.
Patients will receive either M-TAPA or EOI block as part of routine clinical practice. The choice of block will not be influenced by the investigators, in accordance with the observational design of the study. Data will be collected prospectively during the intraoperative period and postoperative follow-up.
The primary outcome of the study is the time-weighted average intraoperative remifentanil infusion rate (µg/kg/min). Secondary outcomes include total intraoperative remifentanil consumption (µg/kg), intraoperative hemodynamic parameters (heart rate and mean arterial pressure), frequency of deviations in SCA values from the target range, postoperative pain scores assessed using a numeric rating scale (NRS), time to first analgesic requirement, and total rescue analgesic consumption.
Perioperative analgesia will be standardized. All patients will receive intravenous dexketoprofen toward the end of surgery as part of routine clinical practice. Rescue analgesia will be provided with intravenous dexketoprofen when clinically indicated. Additional outcomes include postoperative nausea and vomiting and perioperative complications.
This study aims to provide objective data on the opioid-sparing effects of different abdominal wall block techniques when intraoperative analgesia is guided by nociception monitoring. The findings may contribute to optimizing analgesic strategies and improving perioperative pain management in laparoscopic surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18-80 years
ASA physical status I-III
Scheduled for elective laparoscopic cholecystectomy under general anesthesia
Ability to provide written informed consent
Disqualifiers
Patient refusal
Known allergy to local anesthetics
Chronic opioid use or opioid dependence
Neurological or psychiatric disorders affecting pain perception
Trial population
Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia at a tertiary care hospital.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Time-Weighted Mean Intraoperative Remifentanil Infusion Rate
The time-weighted mean intraoperative remifentanil infusion rate will be calculated throughout the surgical period and expressed as micrograms per kilogram per minute (µg/kg/min) based on continuous infusion data.
Secondary outcomes
Postoperative Pain Scores Assessed by Numeric Rating Scale
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Assessments will be performed at rest and during movement.
Time to First Analgesic Requirement
Time to First Analgesic Requirement
Rescue Analgesic Consumption
Total amount of rescue analgesic (dexketoprofen) administered within the first 24 hours postoperatively.
Mean Arterial Pressure
Mean arterial pressure (MAP), expressed in mmHg, will be recorded intraoperatively and compared with baseline values.
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