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Introduction <p>Postoperative pain management poses unique challenges in older adult patients undergoing laparoscopic abdominal tumor surgery. While morphine remains a standard analgesic option, its use in this population is frequently complicated by adverse effects. Tegileridine represents a potential alternative with distinct pharmacological properties that warrant clinical evaluation.</p> Methods <p>This will be a single-center, randomized, assessor-blinded, active-controlled trial. A total of 66 older adult patients undergoing laparoscopic abdominal tumor surgery will be randomized in a 1:1 ratio to receive either tegileridine (0.1&#xa0;mg bolus) or morphine (1&#xa0;mg bolus) via patient-controlled intravenous analgesia.</p> Planned Outcomes <p>The primary endpoint is the incidence of moderate-to-severe movement-related pain (NRS ≥ 4) at 24&#xa0;h postoperatively. Secondary assessments include pain at rest, requirement for rescue analgesia, safety outcomes, and recovery parameters.</p> Trial Registration <p>Registered at the Chinese Clinical Trial Registry on October 14, 2025. Trial Registration Number: ChiCTR2500110485.</p>

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The Analgesic Effect of Tegileridine in Older Adult Patients After Laparoscopic Abdominal Tumor Surgery: Study Protocol for a Randomized Controlled Trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年11月20日

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  • Yu Feng,
  • Guanyu Yang,
  • Pin Zhang,
  • Liumei Li,
  • Jiayao Tian,
  • Yan Wang,
  • Qinjun Chu

摘要

Introduction

Postoperative pain management poses unique challenges in older adult patients undergoing laparoscopic abdominal tumor surgery. While morphine remains a standard analgesic option, its use in this population is frequently complicated by adverse effects. Tegileridine represents a potential alternative with distinct pharmacological properties that warrant clinical evaluation.

Methods

This will be a single-center, randomized, assessor-blinded, active-controlled trial. A total of 66 older adult patients undergoing laparoscopic abdominal tumor surgery will be randomized in a 1:1 ratio to receive either tegileridine (0.1 mg bolus) or morphine (1 mg bolus) via patient-controlled intravenous analgesia.

Planned Outcomes

The primary endpoint is the incidence of moderate-to-severe movement-related pain (NRS ≥ 4) at 24 h postoperatively. Secondary assessments include pain at rest, requirement for rescue analgesia, safety outcomes, and recovery parameters.

Trial Registration

Registered at the Chinese Clinical Trial Registry on October 14, 2025. Trial Registration Number: ChiCTR2500110485.