About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Allergy to PCA medications;
Presence of chronic pain syndromes;
Presence of psychiatric disorders, or severe cardiovascular, cerebrovascular, renal, or hepatic dysfunction.
Trial design
Parallel
Treatments tested in this trial
Fixed-rate basal infusion mode
Procedure/SurgeryAll 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.
Variable-rate feedback infusion mode
Procedure/SurgeryAll 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.
Treatment groups
Trial outcomes
Primary outcomes
Total cumulative opioid consumption
The total cumulative opioid consumption includes sufentanil delivered via PCA and opioid-equivalent rescue analgesics.
Secondary outcomes
Resting and movement pain score was assessed by NRS
NRS ranges from 0 to 10, with the highest score indicating the worst pain.
Cumulative PCA volume consumption
Number of additional rescue analgesics
Dosage of additional rescue analgesics
Sponsors and contacts
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Beijing Tiantan Hospital
Lead sponsor
The Second Affiliated Hospital of Hainan Medical University
Collaborator
Youjiang Medical College for Nationalities
Collaborator