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NCT Number: NCT07375121

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

Location status: Recruiting

Location contact

Fang Luo

CONTACT

[email protected]

59976661

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fixed-rate basal infusion mode

Procedure

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.

Time-programmed decremental background infusion mode

Procedure

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.

Primary outcomes

  1. Cumulative opioid consumption

    Time frame: Within the first 48 hours postoperatively

Secondary outcomes

  1. Resting and movement pain score was assessed by numeric rating scale.

    Time frame: At 1, 6, 12, 24, and 48 hours postoperatively

    Numeric rating scale ranges from 0 to 10, with the highest score indicating the worst pain.

  2. Cumulative patient-controlled analgesia volume consumption

    Time frame: Within the first 48 hours postoperatively

  3. Frequency of additional rescue analgesics

    Time frame: At 1, 6, 12, 24, and 48 hours postoperatively

  4. Dosage of additional rescue analgesics

    Time frame: At 1, 6, 12, 24, and 48 hours postoperatively

  5. Bolus demand frequency

    Time frame: at 1, 6, 12, 24, and 48 hours postoperatively

  6. Postoperative quality of recovery

    Time frame: At 24, and 48 hours postoperatively

    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.

  7. Quality of sleep

    Time frame: 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).

  8. The level of sedation and agitation

    Time frame: At 1, 6, 12, 24, and 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.

  9. The degree of nausea and vomiting

    Time frame: At 1, 6, 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.

  10. The patient's satisfaction with patient-controlled analegsia device

    Time frame: At 48 hours postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo

CONTACT

[email protected]

59976661

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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