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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
450
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.
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.
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China
RECRUITINGCumulative opioid consumption
Time frame: Within the first 48 hours postoperatively
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.
Time frame: At 1, 6, 12, 24, and 48 hours postoperatively
Cumulative patient-controlled analgesia volume consumption
Time frame: Within the first 48 hours postoperatively
Frequency of additional rescue analgesics
Time frame: At 1, 6, 12, 24, and 48 hours postoperatively
Dosage of additional rescue analgesics
Time frame: At 1, 6, 12, 24, and 48 hours postoperatively
Bolus demand frequency
Time frame: at 1, 6, 12, 24, and 48 hours postoperatively
Postoperative quality of recovery
Postoperative quality of recovery was assessed through the Postoperative Quality Recovery Scale 1 day after surgery. It consists of six domains (physiologic, nociceptive, emotive, activities of daily living, cognitive and overall patient perspective). The higher score indicated a better quality of postoperative recovery.
Time frame: At 24, and 48 hours postoperatively
Quality of sleep
Quality of sleep was evaluated on postoperative days 1, 2 and 3 using the Medical Outcomes Study Sleep Scale (MOS). MOS is questionnaire comprising 12 items that assess various aspects of sleep using a 6-point ordinal scale (1 indicating permanence and 6 indicating absence).
Time frame: At 24, and 48 hours postoperatively
The level of sedation and agitation
The level of sedation and agitation was assessed using the Richmond Agitation and Sedation Scale, which ranges from +4 (combative agitation) to -5 (deep sedation), with a score of 0 indicating an alert and calm state.
Time frame: At 1, 6, 12, 24, and 48 hours postoperatively
The degree of nausea and vomiting
The degree of nausea and vomiting, a score from 0 to 10 was given. A score of 0 was given if the patient had no nausea or vomiting, and a score 10 was given if the patient had severe nausea and vomiting.
Time frame: At 1, 6, 12, 24, and 48 hours postoperatively
The patient's satisfaction with patient-controlled analegsia device
The patient's satisfaction with patient-controlled analegsia device during 2 days postoperatively was assessed according to the following scale: 1, very satisfactory; 2, satisfactory; 3, neutral; 4, unsatisfactory; 5; very unsatisfactory.
Time frame: At 48 hours postoperatively
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