Comparison of M-TAPA and External Oblique Intercostal Plane Block on Intraoperative Analgesia and Opioid Consumption Guided by Skin Conductance Algesimeter in Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time-Weighted Mean Intraoperative Remifentanil Infusion Rate
研究概览
简要总结
This prospective, randomized, interventional study compares the effects of modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and external oblique intercostal plane block (EOI) on intraoperative analgesia and opioid consumption in patients undergoing elective laparoscopic cholecystectomy.
Eighty patients are randomized into two groups: the M-TAPA group and the EOI group. All patients receive standardized general anesthesia. Intraoperative analgesia is 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)" is used to assess nociceptive responses, and remifentanil infusion is titrated according to SCA values.
Patients assigned to the M-TAPA group receive bilateral ultrasound-guided M-TAPA block, while patients assigned to the EOI group receive bilateral ultrasound-guided external oblique intercostal plane block. In both groups, 20 mL of 0.25% bupivacaine is administered on each side.
Perioperative analgesia is standardized. All patients receive intravenous dexketoprofen toward the end of surgery. During postoperative follow-up, intravenous paracetamol is administered as rescue analgesia when the numeric rating scale (NRS) pain score is 4 or higher.
The primary outcome is the time-weighted average intraoperative remifentanil infusion rate (µg/kg/min). Secondary outcomes include total intraoperative remifentanil consumption, intraoperative hemodynamic parameters, SCA measurements, postoperative pain scores, time to first rescue analgesic requirement, rescue analgesic consumption, postoperative nausea and vomiting, and perioperative complications.
The study aims to compare the opioid-sparing and analgesic effects of M-TAPA and EOI under objective nociception-guided intraoperative analgesia.
详细描述
This prospective, randomized, interventional study compares modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and external oblique intercostal plane block (EOI) in patients undergoing elective laparoscopic cholecystectomy.
A total of 80 patients are randomized in a 1:1 ratio to either the M-TAPA group or the EOI group. Patients and postoperative outcome assessors are blinded to group allocation. The anesthesiologist performing the block is not blinded because of the nature of the procedures.
All patients receive standardized general anesthesia. Intraoperative analgesia is guided using 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 measure of nociceptive activity. Remifentanil is administered by continuous infusion and titrated according to SCA values to maintain the predefined target range.
Patients randomized to the M-TAPA group receive bilateral ultrasound-guided modified thoracoabdominal nerve block through perichondrial approach. Patients randomized to the EOI group receive bilateral ultrasound-guided external oblique intercostal plane block. In both groups, 20 mL of 0.25% bupivacaine is administered on each side.
Intraoperative data include heart rate, mean arterial pressure, SCA-derived PPS values, and remifentanil infusion rates. The primary outcome is the time-weighted average intraoperative remifentanil infusion rate (µg/kg/min). Secondary outcomes include total intraoperative remifentanil consumption, frequency of SCA values outside the predefined target range, postoperative pain intensity assessed using the numeric rating scale (NRS), time to first rescue analgesic requirement, rescue analgesic consumption during the first 24 postoperative hours, postoperative nausea and vomiting, and perioperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years
- •ASA physical status I-III
- •Scheduled for elective laparoscopic cholecystectomy under general anesthesia
- •Ability to provide written informed consent
排除标准
- •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
研究组 & 干预措施
M-TAPA Group
Patients assigned to this arm received bilateral modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) for perioperative analgesia during laparoscopic cholecystectomy.
干预措施: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) (Procedure)
EOI Group
Patients assigned to this arm received bilateral external oblique intercostal plane block (EOIPB) for perioperative analgesia during laparoscopic cholecystectomy.
干预措施: External Oblique Intercostal Plane Block (EOI) (Procedure)
结局指标
主要结局
Time-Weighted Mean Intraoperative Remifentanil Infusion Rate
时间窗: 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.
次要结局
- Postoperative Pain Scores Assessed by Numeric Rating Scale(0, 2, 4, 6, 12, and 24 hours postoperatively)
- Time to First Analgesic Requirement(Within 24 hours postoperatively)
- Rescue Analgesic Consumption(First 24 hours postoperatively)
- Mean Arterial Pressure(Intraoperative period)
- Heart Rate(Intraoperative period)
- Skin Conductance Algesimeter(SCA)(Intraoperative period)
- Postoperative Nausea and Vomiting (PONV)(First 24 hours postoperatively)
研究者
İsmet Uluhan
Anesthesiology Resident
Ankara Etlik City Hospital