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

NCT07013721 | Not Yet Recruiting

• 1 other identifier: PLAGH-TAPB-002
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Regional Anaesthesia; Transversus abdominis plane block (TAP block); Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Pain score

  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.

  24 hours after surgery

Secondary Outcomes (8)

• 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

Study Arms (2)

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.

Procedure: Transversus Abdominis Plane Block, TAPB

Non-intervention Control Group

NO INTERVENTION

Interventions

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.

transversus abdominis plane block group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

1,3-bis(4-amidinophenoxy)-2-(4-amidinophenoxymethyl)ethylpropane

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Anesthesiology (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 10, 2025
• Study Start: June 2, 2025
• Primary Completion: April 13, 2026
• Study Completion: April 15, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share