NCT07375121

Comparison of the Efficacy and Safety of Fixed-rate Basal Infusion Mode and Time-programmed Decremental Background Infusion Mode of Intravenous PCA Following Mixed Surgery

Prospective Randomized Controlled Study of Individualized PCA Model Based on Multi-dimensional Strategies (Fixed-rate Basal Infusion Mode and Time-programmed Decremental Background Infusion Mode)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Perioperative pain management significantly impacts patient recovery outcomes. However, the incidence of moderate to severe postoperative pain remains high at 73.8%, 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.

Conditions

• Surgery
• Pain Management
• Opioid Consumption
• Patient Controlled Analgesia

Interventions

Type	Name	Description
PROCEDURE	Fixed-rate basal infusion mode	All participants received a standardized PCA solution containing sufentanil (200 μg), ondansetron (32 mg), and normal saline with total volume 200 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.
PROCEDURE	Time-programmed decremental background infusion mode	In the time-programmed decremental infusion group, which served as the intervention group, the bolus dose and lockout interval will remain the same, whereas the background infusion rate will be reduced according to a predefined postoperative schedule designed to match the expected decline in postoperative pain intensity. Specifically, the background infusion rate will be set at 4.0 mL/h during the first 6 postoperative hours, reduced to 3 mL/h from 6 to 12 hours, decreased to 2.0 mL/h from 12 to 24 hours, and further reduced to 1.0 mL/h from 24 to 48 hours after surgery.

Timeline

• Start date: 2025-12-30
• Primary completion: 2026-10-30
• Completion: 2026-12-30
• First posted: 2026-01-29
• Last updated: 2026-04-06

Locations

1 site across 1 country: China