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NCT Number: NCT07361822

Comparison of Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes 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

Conditions

Surgery Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid Consumption Pain Management Pathological Conditions, Signs and Symptoms Patient-Controlled Analgesia Perceptual Disorders Signs and Symptoms

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]

13611326978

About this study

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.

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 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Total cumulative opioid consumption

    Time frame: at 48 hours postoperatively

    The total cumulative opioid consumption includes sufentanil delivered via PCA and opioid-equivalent rescue analgesics.

Secondary outcomes

  1. Resting and movement pain score was assessed by NRS

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

    NRS ranges from 0 to 10, with the highest score indicating the worst pain.

  2. Cumulative PCA volume consumption

    Time frame: Within the first 48 hours postoperatively

  3. Number of additional rescue analgesics

    Time frame: within 48 hours postoperatively

  4. Dosage of additional rescue analgesics

    Time frame: within 48 hours postoperatively

  5. Postoperative quality of recovery

    Time frame: 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.

  6. 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).

  7. The level of sedation and agitation

    Time frame: 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.

  8. The degree of nausea and vomiting

    Time frame: 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.

  9. The patient's satisfaction with PCA

    Time frame: 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.

Study contacts

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

Fang Luo

CONTACT

[email protected]

13611326978

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • The Second Affiliated Hospital of Hainan Medical University
  • Youjiang Medical College for Nationalities

Registry information

Official study title

Prospective Randomized Controlled Study of Individualized PCA Model Based on Multi-dimensional Strategies (Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 23, 2026
Registry last updated
Jun 12, 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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