Transversus Abdominis Plane Block on Postoperative Analgesic Efficacy in Elderly Patients Undergoing Minimally Invasive Gastrointestinal Tumor Surgery

Not Applicable

Not yet recruiting

• Conditions: Regional Anaesthesia; Transversus Abdominis Plane Block (TAP Block); Pain, Postoperative

• Registration Number: NCT07013721
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-22
• Study Start: 2025-06-02
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Primary Completion: 2026-04-13
• Study Completion: 2026-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain score	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	From surgery to hospital discharge (up to 4 weeks).	Postoperative analgesia satisfaction is assessed using an 11-point Numerical Rating Scale (NRS), where 0 = "completely dissatisfied" and 10 = "completely satisfied".
Adverse reactions: Dizziness, nausea and vomiting	Postoperative Day 1-5
the use of a patient-controlled analgesia (PCA) pump	Three days after surgery
length of hospital stay	No more than 4 weeks
pain score	1, 6, and 48 hours after surgery	Resting and movement 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.
postoperative delirium during hospitalization	Postoperaitve Day 1-5	The 3D-CAM (3-Minute Diagnostic Interview for CAM-defined Delirium) is a standardized rapid bedside assessment for delirium screening. It evaluates four core features: (1) Acute onset/fluctuating course, (2) Inattention, (3) Disorganized thinking, and (4) Altered level of consciousness. A positive delirium diagnosis requires: Feature 1 AND Feature 2 to be present concurrently, plus at least one of Feature 3 OR Feature 4.
consumption of sufentanil	During the operation
Subjective sleep quality score	The first postoperative day	Using the scaleRichards-Campbell Sleep Questionnaire (RCSQ) scale. The Richards-Campbell Sleep Questionnaire (RCSQ) is a patient-reported visual analog scale assessing sleep quality in critically ill patients. It evaluates five domains: sleep depth, sleep latency (ease of falling asleep), awakenings (frequency of disruption), sleep efficiency (returning to sleep), and overall sleep quality. Patients mark each item on a 100-mm line (0 = "worst possible" to 100 = "best possible"). The total score is the mean of all domains (range: 0-100), with higher scores indicating better sleep. Administration requires ≤3 minutes and is completed by alert patients upon waking.