Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07013721

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Regional Anaesthesia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Transversus Abdominis Plane Block (TAP Block)

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transversus Abdominis Plane Block, TAPB

Procedure

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.

Primary outcomes

  1. Pain score

    Time frame: 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 outcomes

  1. pain score

    Time frame: 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.

  2. postoperative delirium during hospitalization

    Time frame: 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.

  3. consumption of sufentanil

    Time frame: During the operation

  4. Subjective sleep quality score

    Time frame: 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.

  5. the use of a patient-controlled analgesia (PCA) pump

    Time frame: Three days after surgery

  6. length of hospital stay

    Time frame: No more than 4 weeks

  7. Patient satisfaction

    Time frame: 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".

  8. Adverse reactions: Dizziness, nausea and vomiting

    Time frame: Postoperative Day 1-5

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.