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 thoracoscopic surgery, laparoscopic surgery, hysteroscopy surgery, laparotomy, thoracotomy, open spinal surgery, craniotomy, and so on.
Disqualifiers
Chronic pain syndromes;
Psychiatric disorders;
Severe cardiovascular or cerebrovascular disease, renal or hepatic functional dysfunction, or allergic to PCA medications.
Trial design
Parallel
Treatments tested in this trial
Fixed-rate basal infusion mode
Procedure/SurgeryAll 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.
Time-programmed decremental background infusion mode
Procedure/SurgeryIn 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.
Treatment groups
Trial outcomes
Primary outcomes
Cumulative opioid consumption
Secondary outcomes
Resting and movement pain score was assessed by numeric rating scale.
Numeric rating scale ranges from 0 to 10, with the highest score indicating the worst pain.
Cumulative patient-controlled analgesia volume consumption
Frequency of additional rescue analgesics
Dosage of additional rescue analgesics
Sponsors and contacts
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