跳至主要内容
临床试验/NCT07666646
NCT07666646招募中不适用

Comparison of the Effects of Erector Spinae Plane Block and Modified Thoracoabdominal Nerve Block Through Perichondrial Approach on Postoperative Pulmonary Function and Analgesic Consumption in Patients Undergoing Laparoscopic Cholecystectomy

Kayseri City Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年8月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Forced Expiratory Volume in 1 Second (FEV1)

研究概览

简要总结

This prospective, randomized, controlled clinical trial aims to compare the effects of two ultrasound-guided fascial plane blocks, the Erector Spinae Plane Block (ESPB) and the Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA), on postoperative pulmonary function and analgesic consumption in patients undergoing laparoscopic cholecystectomy. Laparoscopic cholecystectomy is one of the most frequently performed abdominal surgical procedures worldwide. Despite minimally invasive techniques, postoperative pain remains a significant clinical problem due to port-site trauma, pneumoperitoneum, diaphragmatic irritation, and visceral manipulation.

Inadequate pain control may lead to impaired respiratory mechanics, reduced mobilization, delayed recovery, and an increased risk of postoperative pulmonary complications. Postoperative pulmonary dysfunction is a common consequence of upper abdominal surgery and may persist for several days, contributing to reductions in forced vital capacity (FVC) and forced expiratory volume in one second (FEV1), which are associated with increased postoperative morbidity.

Although opioid-based analgesia is widely used, it is associated with adverse effects such as respiratory depression, nausea, vomiting, ileus, and delayed recovery. Therefore, regional anesthesia techniques and multimodal analgesia strategies are increasingly recommended to reduce opioid consumption while improving pain control.

ESPB and M-TAPA are ultrasound-guided fascial plane blocks used for postoperative analgesia in abdominal surgery. ESPB provides somatic and visceral analgesia through the spread of local anesthetic affecting the spinal nerve rami, while M-TAPA targets the anterior branches of the thoracoabdominal nerves to provide extensive anterior and lateral abdominal wall analgesia.

Despite their increasing use, there is limited high-quality comparative evidence evaluating the effects of ESPB and M-TAPA on postoperative pulmonary function and opioid consumption in laparoscopic cholecystectomy. This study compares these two regional anesthesia techniques in a randomized controlled design to evaluate their impact on postoperative respiratory function and analgesic requirements.

详细描述

This study is a prospective, randomized, controlled clinical trial designed to compare the effects of two ultrasound-guided fascial plane blocks, the Erector Spinae Plane Block (ESPB) and the Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA), on postoperative pulmonary function and analgesic consumption in patients undergoing laparoscopic cholecystectomy.

A total of 60 patients will be randomly allocated into two groups: ESPB group (n=30) and M-TAPA group (n=30). All patients will undergo standard general anesthesia. After induction of general anesthesia and before surgical incision, regional blocks will be performed.

Patients in the ESPB group will receive bilateral ultrasound-guided erector spinae plane block at the T9 vertebral level using 0.25% bupivacaine, 20 mL per side (total 40 mL). Patients in the M-TAPA group will receive bilateral ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach using the same concentration and volume of local anesthetic (0.25% bupivacaine, total 40 mL).

All blocks will be performed under sterile conditions using a high-frequency linear ultrasound probe and an 80 mm echogenic needle.

All patients will receive standardized multimodal analgesia, including intravenous paracetamol (1 g every 8 hours) and intravenous ibuprofen (400 mg every 12 hours) for 24 hours postoperatively. The first doses of paracetamol and ibuprofen will be administered 10 minutes before the end of surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 18-70 years
  • •American Society of Anesthesiologists (ASA) physical status I-III
  • •Patients scheduled for elective laparoscopic cholecystectomy
  • •Patients who provide written informed consent
  • •Patients who are able to cooperate and perform pulmonary function tests (PFTs)

排除标准

  • •Coagulation disorders or anticoagulant therapy contraindicating regional anesthesia
  • •Infection at the planned block site
  • •Known allergy to local anesthetic agents
  • •Conversion to open surgery
  • •Hemodynamic instability
  • •Inability to cooperate with pulmonary function tests (PFTs)
  • •Pre-existing severe pulmonary disease (e.g., severe chronic obstructive pulmonary disease or restrictive lung disease)
  • •Chronic opioid use or opioid dependence
  • •Pregnancy or breastfeeding
  • •Active smokers
  • •Body mass index (BMI) > 35 kg/m²

研究组 & 干预措施

M-TAPA Block

Experimental

An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally with local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.

干预措施: Modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) (Procedure)

Erector spinae plane block (ESPB)

Experimental

An ultrasound-guided erector spinae plane block (ESPB) performed with local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.

干预措施: Erector spinae plane block (ESPB) (Procedure)

结局指标

主要结局

Forced Expiratory Volume in 1 Second (FEV1)

时间窗: Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.

Forced expiratory volume in one second (FEV1, liters) will be measured to assess postoperative pulmonary function.

Forced Vital Capacity (FVC)

时间窗: Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.

Forced vital capacity (FVC, liters) will be measured to assess postoperative pulmonary function.

FEV1/FVC Ratio

时间窗: Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.

The FEV1/FVC ratio (percentage, %) will be measured to assess postoperative pulmonary function.

Peak Expiratory Flow (PEF)

时间窗: Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.

Peak expiratory flow (PEF, liters/minute) will be measured to assess postoperative pulmonary function.

次要结局

  • Total Opioid Consumption(First 24 postoperative hours)
  • Postoperative Pain Scores (NRS)(Postoperative 1st, 6th, 12th, 18th, and 24th hours)
  • Quality of Recovery-15 (QoR-15)(24 hours postoperatively)

研究者

发起方
Kayseri City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Muhammed Nail Tekcan

Medical Doctor, Department of Anesthesiology and Reanimation

Kayseri City Hospital

研究点 (1)

Loading locations...

相似试验