RecruitingNot ApplicableNCT07361822

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

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)

Sponsor

Beijing Tiantan Hospital

Enrollment

426 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

Surgery Pain Management Patient-controlled Analgesia Opioid Consumption

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

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 thoracoscopic surgery, laparoscopic surgery, hysteroscopy surgery, laparotomy, thoracotomy, open spinal surgery, craniotomy, and so on.

Exclusion Criteria3

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

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Interventions

PROCEDUREFixed-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.

PROCEDUREVariable-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 for 1 hour. The background infusion rate was limited to a maximum of 12.0 mL/h and a minimum of 1 mL/h. The specific variable-rate feedback infusion mode setting was based on previous research, and the opinions of manufacturers and researchers to ensure patient safety and to provide effective analgesia.