Clinical trial NCT07013721: Transversus Abdominis Plane Block on Postoperative Analgesic Efficacy in Elderly Patients Undergoing Minimally Invasive Gastrointestinal Tumor Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Regional Anaesthesia
Transversus Abdominis Plane Block (TAP Block)
Pain, Postoperative
Keywords: Regional Anaesthesia
Transversus abdominis plane block (TAP block)
Pain, Postoperative
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 102
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Allergy to anesthetic agents
2. Preoperative chronic pain or chronic use of opioids/nonsteroidal anti-inflammatory drugs (NSAIDs)
3. Contraindications to regional blockade:Local infection at puncture site

   , Coagulopathy (INR \>1.5, platelet count \<80×10⁹/L)
4. There is cognitive impairment, which is determined based on Mini Mental State Examination (MMSE) scores below the standard threshold
5. Preoperative neurological/psychiatric disorders:Consciousness alterations, Epilepsy, Alzheimer's disease, Parkinson's disease, Schizophrenia, Anxiety or depressive disorders, Hepatic, pulmonary, or renal encephalopathy
6. Recent stroke history
7. Postoperative admission to intensive care unit (ICU)

Primary outcomes:
measure: Pain score
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: pain score
timeFrame: 1, 6, and 48 hours after surgery
measure: postoperative delirium during hospitalization
timeFrame: Postoperaitve Day 1-5
measure: consumption of sufentanil
timeFrame: During the operation
measure: Subjective sleep quality score
timeFrame: The first postoperative day
measure: the use of a patient-controlled analgesia (PCA) pump
timeFrame: Three days after surgery
measure: length of hospital stay
timeFrame: No more than 4 weeks
measure: Patient satisfaction
timeFrame: From surgery to hospital discharge (up to 4 weeks).
measure: Adverse reactions: Dizziness, nausea and vomiting
timeFrame: Postoperative Day 1-5
Other outcomes:
Locations:
Study officials:
References: