Comparison of Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes of Intravenous PCA Following Mixed Surgery

Официальное название

Prospective Randomized Controlled Study of Individualized PCA Model Based on Multi-dimensional Strategies (Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes)

Обзор

Perioperative pain management affects patient recovery. However, the rate of moderate to severe postoperative pain is as high as 73.8%, which hinders recovery and increases the risk of complications. Although opioids are the first-line analgesics, excessive use leads to adverse reactions. The traditional fixed-rate PCA mode is difficult to match the changes in postoperative pain. This study will compare different PCA mode optimization strategies, assuming that they can reduce opioid dosage, improve analgesic effect, and reduce adverse reactions, providing high-quality evidence-based basis for postoperative analgesia and promoting individualized and intelligent management.

Подробное описание

Perioperative pain management significantly impacts patient recovery outcomes. However, the incidence of moderate to severe postoperative pain remains high at 80%, which impedes recovery and increases complication risks. Although opioids serve as first-line analgesics, excessive use causes numerous adverse reactions. The traditional fixed-rate Patient-Controlled Analgesia (PCA) mode fails to adapt to dynamic postoperative pain variations. This study will compare different PCA optimization strategies, hypothesizing that these approaches can reduce opioid dosage, enhance analgesic effectiveness, and minimize adverse reactions. The research aims to provide evidence-based foundations for postoperative analgesia, promoting individualized and intelligent pain management systems that better serve patient needs throughout recovery.

Вмешательства

• Процедура Fixed-rate basal infusion mode
  All participants received a standardized PCA solution containing sufentanil (100 μg), ondansetron (16 mg), and normal saline with total volume 100 mL. In conventional fixed-rate basal infusion mode group, the PCA was set to administer a bolus of 2 mL with a lock out interval of 15 minutes and background infusion rate 2 mL/h.
• Процедура Variable-rate feedback infusion mode
  All participants received a standardized PCA solution containing sufentanil (100 μg), ondansetron (16 mg), and normal saline with total volume 100 mL. In variable-rate feedback infusion mode group, a bolus of 2 mL with a lock out interval of 15 minutes and background infusion rate 2 mL/h, which increased to 2.5 mL/h, was used whenever the demand dose was administered within lock out interval. The background infusion rate automatically decreased by 0.5 mL/h when the bolus button was not pressed f

Первичные конечные точки

• Total cumulative opioid consumption [Срок оценки: at 48 hours postoperatively]

Вторичные конечные точки (9)

• Resting and movement pain score was assessed by NRS [Срок оценки: At 1, 6, 12, 24, and 48 hours postoperatively]
• Cumulative PCA volume consumption [Срок оценки: Within the first 48 hours postoperatively]
• Number of additional rescue analgesics [Срок оценки: within 48 hours postoperatively]
• Dosage of additional rescue analgesics [Срок оценки: within 48 hours postoperatively]
• Postoperative quality of recovery [Срок оценки: At 24 hours postoperatively]
• Quality of sleep [Срок оценки: At 24, and 48 hours postoperatively]
• The level of sedation and agitation [Срок оценки: within 48 hours postoperatively]
• The degree of nausea and vomiting [Срок оценки: At 12, 24, and 48 hours postoperatively]
• The patient's satisfaction with PCA [Срок оценки: At 48 hours postoperatively]

Критерии участия

Критерии включения

• aged between 18 to 65 years;
• American Society of Anesthesiologists physical status Ⅰ - Ⅲ;
• Patients scheduled for elective mixed surgery were enrolled. Mixed surgeries included thoracic, abdominal, spinal, orthopaedic, and cranial procedures performed using either minimally invasive or open approaches.

Критерии исключения

• Allergy to PCA medications;
• Presence of chronic pain syndromes;
• Presence of psychiatric disorders, or severe cardiovascular, cerebrovascular, renal, or hepatic dysfunction.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital, Beijing, Beijing 100070 — Пекин

Идентификаторы

NCT: NCT07361822 · KY2025-387-02-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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