Official Title
Comparison of M-TAPA and External Oblique Intercostal Plane Block on Intraoperative Analgesia and Opioid Consumption Guided by Skin Conductance Algesimeter in Laparoscopic Cholecystectomy
Brief Summary

This prospective observational study is designed to evaluate the effects of modifiedthoracoabdominal nerve block through perichondrial approach (M-TAPA) and external obliqueintercostal (EOI) plane block on intraoperative analgesia and opioid consumption inpatients undergoing elective laparoscopic cholecystectomy. Abdominal wall blocks arewidely used to improve perioperative analgesia; however, their impact on intraoperativeopioid requirements when guided by objective nociception monitoring remains unclear.All patients will receive standardized general anesthesia. Intraoperative analgesia willbe guided using the Skin Conductance Algesimeter (SCA), which reflects sympatheticnervous system activity by measuring fluctuations in skin conductance. The SCA parameter"peaks per second (PPS)" will be used to assess nociceptive responses. Remifentanilinfusion will be titrated according to SCA values to maintain adequate analgesia. Doseadjustments will be performed at predefined intervals, and changes will be consideredvalid 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 theobservational design of the study. Data will be collected prospectively during theintraoperative period and postoperative follow-up.The primary outcome of the study is the time-weighted average intraoperative remifentanilinfusion rate (µg/kg/min). Secondary outcomes include total intraoperative remifentanilconsumption (µg/kg), intraoperative hemodynamic parameters (heart rate and mean arterialpressure), frequency of deviations in SCA values from the target range, postoperativepain scores assessed using a numeric rating scale (NRS), time to first analgesicrequirement, and total rescue analgesic consumption.Perioperative analgesia will be standardized. All patients will receive intravenousdexketoprofen toward the end of surgery as part of routine clinical practice. Rescueanalgesia will be provided with intravenous dexketoprofen when clinically indicated.Additional outcomes include postoperative nausea and vomiting and perioperativecomplications.This study aims to provide objective data on the opioid-sparing effects of differentabdominal wall block techniques when intraoperative analgesia is guided by nociceptionmonitoring. The findings may contribute to optimizing analgesic strategies and improvingperioperative pain management in laparoscopic surgery.

Detailed Description

This prospective observational study evaluates intraoperative opioid requirements under
nociception-guided analgesia in patients undergoing elective laparoscopic
cholecystectomy. Analgesic management is guided by the Skin Conductance Algesimeter
(SCA), which reflects sympathetic activation through fluctuations in palmar skin
conductance. The SCA-derived parameter "peaks per second (PPS)" is used as a real-time
surrogate of nociceptive activity.

General anesthesia is administered according to institutional standards. Remifentanil is
delivered via continuous infusion and titrated in response to SCA values to maintain a
predefined nociception-analgesia balance. Dose adjustments are performed in stepwise
increments, with changes considered valid only if sustained over a defined period.
Hemodynamic variables are monitored concurrently but are not the primary determinants of
opioid titration.

Abdominal wall analgesia is provided using either modified thoracoabdominal nerve block
through perichondrial approach (M-TAPA) or external oblique intercostal (EOI) plane
block, both applied as part of routine clinical practice. In line with the observational
design, no allocation or intervention is performed by the investigators, and block
selection is based on standard clinical decision-making.

Intraoperative data are recorded at fixed time intervals, including heart rate, mean
arterial pressure, SCA-derived PPS values, and remifentanil infusion rates. The primary
endpoint is the time-weighted average remifentanil infusion rate (µg/kg/min), reflecting
overall intraoperative opioid requirement normalized to surgical duration. Secondary
analyses include total opioid exposure, frequency and magnitude of deviations from target
nociception ranges, and perioperative analgesic requirements.

Intravenous dexketoprofen is administered toward the end of surgery as part of routine
clinical care. Postoperative outcomes include pain intensity assessed using a numeric
rating scale (NRS), time to first analgesic request, and additional analgesic
consumption. Postoperative nausea, vomiting, and perioperative adverse events are also
recorded.

This study aims to characterize the relationship between nociception-guided opioid
titration and regional anesthesia techniques, and to determine the relative contribution
of abdominal wall blocks to intraoperative opioid sparing under objective monitoring
conditions.

Recruiting
Laparoscopic Cholecystectomy Surgery
Perioperative Analgesia
Eligibility Criteria

Inclusion Criteria:

- Patients aged 18-80 years

- ASA physical status I-III

- Scheduled for elective laparoscopic cholecystectomy under general anesthesia

- Ability to provide written informed consent

Exclusion Criteria:

- Patient refusal

- Known allergy to local anesthetics

- Chronic opioid use or opioid dependence

- Neurological or psychiatric disorders affecting pain perception

- Use of medications affecting autonomic nervous system activity, such as
beta-blockers

- Infection at the injection site

- Coagulopathy or anticoagulant therapy

- Pregnancy

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Turkey (Türkiye)
Locations

Ankara etlik city hospital
Ankara, Yenimahalle, Turkey (Türkiye)

Investigator: İsmet Uluhan, MF
Contact: +905077128389
ismetuluhan@outlook.com

Contacts

İsmet Uluhan, MD
+905077128389
ismtptlk@gmail.com

Not Provided

Ankara Etlik City Hospital
NCT Number
Keywords
m-tapa
External oblique intercostal block
Abdominal Wall Block
Skin Conductance Algesimeter
Remifentanil
opioid consumption
laparoscopic cholecystectomy
Intraoperative Analgesia