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

Overview

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.

Interventions

• Procedure Transversus Abdominis Plane Block, TAPB
  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 o

Primary outcome measures

• Pain score [Time frame: 24 hours after surgery]

Secondary outcome measures (8)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07013721 · PLAGH-TAPB-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗