Comparison of the Efficacy and Safety of Fixed-rate Basal Infusion Mode and Time-programmed Decremental Background Infusion Mode of Intravenous PCA Following Mixed Surgery

Prospective Randomized Controlled Study of Individualized PCA Model Based on Multi-dimensional Strategies (Fixed-rate Basal Infusion Mode and Time-programmed Decremental Background Infusion Mode)

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Pain Management; Opioid Consumption; Patient Controlled Analgesia
• Intervention / Treatment: Procedure: Fixed-rate basal infusion mode; Procedure: Time-programmed decremental background infusion mode

Detailed Description

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
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Luo; Phone Number: 59976661; Email: 13611326978@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tiantan Hospital, Beijing, Beijing 100070
    • Contact: Fang Luo; Phone Number: 59976661; Email: 13611326978@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 thoracoscopic surgery, laparoscopic surgery, hysteroscopy surgery, laparotomy, thoracotomy, open spinal surgery, craniotomy, and so on.

Exclusion Criteria:

• Chronic pain syndromes;
• Psychiatric disorders;
• Severe cardiovascular or cerebrovascular disease, renal or hepatic functional dysfunction, or allergic to PCA medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fixed-rate basal infusion mode group	Procedure: Fixed-rate basal infusion mode; 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.
Experimental: time-programmed decremental background infusion mode group	Procedure: Time-programmed decremental background infusion mode; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative opioid consumption	Within the first 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	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.	At 24, and 48 hours postoperatively
Cumulative patient-controlled analgesia volume consumption		Within the first 48 hours postoperatively
Frequency of additional rescue analgesics		At 1, 6, 12, 24, and 48 hours postoperatively
Dosage of additional rescue analgesics		At 1, 6, 12, 24, and 48 hours postoperatively
Bolus demand frequency		at 1, 6, 12, 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.	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.	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.	At 48 hours postoperatively

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Publications and helpful links

Helpful Links

• 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.
• Momeni M, Crucitti M, De Kock M. Patient-controlled analgesia in the management of postoperative pain. Drugs. 2006;66(18):2321-37.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: KY2025-387-02-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No