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| Name | Class |
|---|---|
| The Second Affiliated Hospital of Hainan Medical University | OTHER |
| Youjiang Medical College for Nationalities | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed-rate basal infusion mode group | Active Comparator |
| |
| Variable-rate feedback infusion mode group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed-rate basal infusion mode | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total cumulative opioid consumption | The total cumulative opioid consumption includes sufentanil delivered via PCA and opioid-equivalent rescue analgesics. | at 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Resting and movement pain score was assessed by NRS | NRS ranges from 0 to 10, with the highest score indicating the worst pain. | At 1, 6, 12, 24, and 48 hours postoperatively |
| Cumulative PCA volume consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo | Contact | 13611326978 | 13611326978@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Beijing, Beijing 100070 | Recruiting | Beijing | China |
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| Label | URL |
|---|---|
| Mitra S, Carlyle D, Kodumudi G, Kodumudi V, Vadivelu N. New Advances in Acute Postoperative Pain Management. Curr Pain Headache Rep. 2018;22(5):35. | View source |
| Momeni M, Crucitti M, De Kock M. Patient-controlled analgesia in the management of postoperative pain. Drugs. 2006;66(18):2321-37. | View source |
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Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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|
| Variable-rate feedback infusion mode | Procedure | 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. |
|
| 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 | 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. | At 24 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). | 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. | within 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. | At 12, 24, and 48 hours postoperatively |
| The patient's satisfaction with PCA | 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. | At 48 hours postoperatively |
| Jung KT, So KY, Kim SU, Kim SH. The Optimizing Background Infusion Mode Decreases Intravenous Patient-Controlled Analgesic Volume and Opioid Consumption Compared to Fixed-Rate Background Infusion in Patients Undergoing Laparoscopic Cholecystectomy: A Pro | View source |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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