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

NCT ID: NCT07013721

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-02
• Study Completion Date: 2026-04-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

transversus abdominis plane block group

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.

Group Type: EXPERIMENTAL

Transversus Abdominis Plane Block, TAPB

Intervention Type: 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.

Non-intervention Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Weidong Mi

Director, Department of Anesthesiology (Cheif expert of National key research and development program of China 2018YFC2001900)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PLAGH-TAPB-002

Identifier Type: -

Identifier Source: org_study_id