Opioid Consumption, Pain Management, Patient-controlled Analgesia, Surgery
Conditions
Brief 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 80%, 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.
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.
Sponsors
Beijing Tiantan Hospital
The Second Affiliated Hospital of Hainan Medical University
Youjiang Medical College for Nationalities
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Allergy to PCA medications; * Presence of chronic pain syndromes; * Presence of psychiatric disorders, or severe cardiovascular, cerebrovascular, renal, or hepatic dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total cumulative opioid consumption | at 48 hours postoperatively | The total cumulative opioid consumption includes sufentanil delivered via PCA and opioid-equivalent rescue analgesics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting and movement pain score was assessed by NRS | At 1, 6, 12, 24, and 48 hours postoperatively | NRS ranges from 0 to 10, with the highest score indicating the worst pain. |
| Cumulative PCA volume consumption | Within the first 48 hours postoperatively | — |
| Number of additional rescue analgesics | within 48 hours postoperatively | — |
| Dosage of additional rescue analgesics | within 48 hours postoperatively | — |
| Postoperative quality of recovery | At 24 hours postoperatively | Postoperative quality of recovery was assessed through the Postoperative Quality of Recovery-15 questionnaire 1 day after surgery. It consists of six domains (physiologic, nociceptive, emotive, activities of daily living, cognitive and overall patient perspective). The score ranges from 0 to 150, with higher score indicating a better quality of postoperative recovery. |
| Quality of sleep | At 24, and 48 hours postoperatively | 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). |
| The level of sedation and agitation | within 48 hours postoperatively | 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. |
| The degree of nausea and vomiting | At 12, 24, and 48 hours postoperatively | 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. |
| The patient's satisfaction with PCA | At 48 hours postoperatively | The patient's satisfaction with PCA during 2 days postoperatively was assessed according to the following scale: 1, very satisfactory; 2, satisfactory; 3, neutral; 4, unsatisfactory; 5; very unsatisfactory. |
Countries
China
Contacts
CONTACTFang Luo
Outcome results
None listed