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Recruiting NCT07361822

Comparison of Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes of Intravenous PCA Following Mixed Surgery

No phase Interventional Surgery Pain Management Opioid Consumption Patient-controlled Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fixed-rate basal infusion mode, Variable-rate feedback infusion mode.
Who it may be relevant to
Registry conditions: Surgery, Pain Management, Opioid Consumption, Patient-controlled Analgesia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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)

Overview

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

  • Procedure Fixed-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.
  • Procedure Variable-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 f

Primary outcome measures

  • Total cumulative opioid consumption [Time frame: at 48 hours postoperatively]
Secondary outcome measures (9)
  • Resting and movement pain score was assessed by NRS [Time frame: At 1, 6, 12, 24, and 48 hours postoperatively]
  • Cumulative PCA volume consumption [Time frame: Within the first 48 hours postoperatively]
  • Number of additional rescue analgesics [Time frame: within 48 hours postoperatively]
  • Dosage of additional rescue analgesics [Time frame: within 48 hours postoperatively]
  • Postoperative quality of recovery [Time frame: At 24 hours postoperatively]
  • Quality of sleep [Time frame: At 24, and 48 hours postoperatively]
  • The level of sedation and agitation [Time frame: within 48 hours postoperatively]
  • The degree of nausea and vomiting [Time frame: At 12, 24, and 48 hours postoperatively]
  • The patient's satisfaction with PCA [Time frame: At 48 hours postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing

Identifiers

NCT: NCT07361822 · KY2025-387-02-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗