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临床试验/NCT07013721
NCT07013721尚未招募不适用

A Clinical Study on the Effect of Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Analgesic Efficacy in Elderly Patients Undergoing Minimally Invasive Gastrointestinal Tumor Surgery

Chinese PLA General Hospital0 个研究点目标入组 102 人开始时间: 2025年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
102
主要终点
Pain score

研究概览

简要总结

Elderly patients undergoing minimally invasive gastrointestinal tumor surgery face complex postoperative pain management due to age-related physiological decline and surgical particularities, where traditional opioids are prone to adverse effects. Our study investigates the clinical analgesic efficacy of ultrasound-guided transversus abdominis plane block (TAPB) in these patients, focusing on analgesic quality, delirium incidence, opioid consumption, and postoperative recovery indicators. This evaluation aims to assess its clinical value and safety while providing evidence-based insights for optimizing perioperative analgesia protocols.

详细描述

Globally, approximately 30% of surgical patients experience moderate to severe acute postoperative pain annually, with 11% developing severe acute postoperative pain. Inadequate pain control and analgesic administration may precipitate adverse outcomes such as postoperative delirium, a complication particularly prevalent in elderly populations. The concept of multimodal analgesia has emerged to enhance therapeutic efficacy, mitigate adverse effects associated with monotherapy, accelerate postoperative rehabilitation, and improve patient satisfaction. The transversus abdominis plane block constitutes a critical component of multimodal analgesic strategies.

This randomized controlled trial was conducted to compare the differences in postoperative analgesic efficacy between the transversus abdominis plane block intervention group and the non-intervention control group among elderly patients undergoing minimally invasive gastrointestinal tumor surgery. Key evaluation parameters included postoperative pain intensity (assessed via validated pain scales), incidence of postoperative delirium, opioid consumption , and comprehensive postoperative recovery metrics (e.g., length of hospitalization). The study concurrently evaluated the clinical safety profile of transversus abdominis plane block through systematic monitoring of procedure-related complications and adverse events, thereby providing evidence-based data to refine perioperative analgesic protocols and optimize Enhanced Recovery After Surgery (ERAS) pathways in geriatric surgical populations.

研究设计

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Elderly patients scheduled for elective minimally invasive gastrointestinal tumor surgery under general anesthesia
  • •Age ≥65 years
  • •American Society of Anesthesiologists (ASA) physical status classification ≤III
  • •Body mass index (BMI) 18-30 kg/m²

排除标准

  • •Allergy to anesthetic agents
  • •Preoperative chronic pain or chronic use of opioids/nonsteroidal anti-inflammatory drugs (NSAIDs)
  • •Contraindications to regional blockade:Local infection at puncture site
  • •, Coagulopathy (INR >1.5, platelet count <80×10⁹/L)
  • •There is cognitive impairment, which is determined based on Mini Mental State Examination (MMSE) scores below the standard threshold
  • •Preoperative neurological/psychiatric disorders:Consciousness alterations, Epilepsy, Alzheimer's disease, Parkinson's disease, Schizophrenia, Anxiety or depressive disorders, Hepatic, pulmonary, or renal encephalopathy
  • •Recent stroke history
  • •Postoperative admission to intensive care unit (ICU)

研究组 & 干预措施

transversus abdominis plane block group

Experimental

The procedure was performed by anesthesiologists with extensive expertise in nerve blockade techniques. For upper abdominal surgical incisions, a subcostal approach transversus abdominis plane block (TAPB) was implemented under ultrasound guidance to identify the transversus abdominis plane. A total of 20 mL of 0.33% ropivacaine hydrochloride injection (Naropin®) was incrementally administered, followed by contralateral application using identical techniques, with ultrasonographic confirmation of fusiform drug distribution within the transversus abdominis plane to achieve upper abdominal incision analgesia. For lower abdominal incisions, a lateral approach was employed, with the same dosage of local anesthetic injected at the target site and bilateral blocks performed after confirming fluid dispersion patterns under real-time ultrasound visualization.

干预措施: Transversus Abdominis Plane Block, TAPB (Procedure)

Non-intervention Control Group

No Intervention

结局指标

主要结局

Pain score

时间窗: 24 hours after surgery

Pain scores using Numerical Rating Scale (NRS). The Numerical Rating Scale (NRS) assesses pain intensity through patient self-reporting on an 11-point scale ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Patients independently select a single number reflecting their current pain level without clinician interpretation.

次要结局

  • pain score(1, 6, and 48 hours after surgery)
  • postoperative delirium during hospitalization(Postoperaitve Day 1-5)
  • consumption of sufentanil(During the operation)
  • Subjective sleep quality score(The first postoperative day)
  • the use of a patient-controlled analgesia (PCA) pump(Three days after surgery)
  • length of hospital stay(No more than 4 weeks)
  • Patient satisfaction(From surgery to hospital discharge (up to 4 weeks).)
  • Adverse reactions: Dizziness, nausea and vomiting(Postoperative Day 1-5)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weidong Mi

Director, Department of Anesthesiology (Cheif expert of National key research and development program of China 2018YFC2001900)

Chinese PLA General Hospital

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