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Comparison of M-TAPA and External Oblique Intercostal Block for Intraoperative Opioid Consumption in Laparoscopic Cholecystectomy (MTAPA-EOI)

2026年6月6日 更新者:İsmet Uluhan、Ankara Etlik City Hospital

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

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia at a tertiary care hospital.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
M-TAPA Group
Patients receiving ePatients receiving modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) for intraoperative analgesia during laparoscopic cholecystectomy.ternal oblique intercostal plane block (EOI) for analgesia
EOI Group
Patients receiving external oblique intercostal plane (EOI) block for intraoperative analgesia during laparoscopic cholecystectomy.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Time-Weighted Mean Intraoperative Remifentanil Infusion Rate
大体时间:Intraoperative period (from induction to end of surgery)
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.
Intraoperative period (from induction to end of surgery)

次要结果测量

结果测量
措施说明
大体时间
Postoperative Pain Scores Assessed by Numeric Rating Scale
大体时间:0, 2, 4, 6, 12, and 24 hours postoperatively
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.
0, 2, 4, 6, 12, and 24 hours postoperatively
Time to First Analgesic Requirement
大体时间:Within 24 hours postoperatively
Time to First Analgesic Requirement
Within 24 hours postoperatively
Rescue Analgesic Consumption
大体时间:First 24 hours postoperatively
Total amount of rescue analgesic (dexketoprofen) administered within the first 24 hours postoperatively.
First 24 hours postoperatively
Mean Arterial Pressure
大体时间:Intraoperative period
Mean arterial pressure (MAP), expressed in mmHg, will be recorded intraoperatively and compared with baseline values.
Intraoperative period
Heart Rate
大体时间:Intraoperative period
Heart rate, expressed as beats per minute, will be recorded intraoperatively and compared with baseline values.
Intraoperative period
Skin Conductance Algesimeter(SCA)
大体时间:Intraoperative period
Skin Conductance Algesimeter (SCA) peaks per second (PPS) values recorded intraoperatively to assess nociceptive responses.
Intraoperative period
Postoperative Nausea and Vomiting (PONV)
大体时间:First 24 hours postoperatively
Incidence of postoperative nausea and vomiting within the first 24 hours after surgery.
First 24 hours postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月15日

初级完成 (估计的)

2026年8月1日

研究完成 (估计的)

2026年9月1日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年5月15日

首次发布 (实际的)

2026年5月19日

研究记录更新

最后更新发布 (实际的)

2026年6月9日

上次提交的符合 QC 标准的更新

2026年6月6日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared in accordance with institutional policies

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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