Comparing adjustable feedback IV patient-controlled pain pumps with fixed-rate pumps after surgery.
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)
Run by Beijing Tiantan Hospital · NCT07361822 · Data updated 2026-11-12
This study will test whether an adjustable feedback IV patient-controlled pain pump can reduce opioid use and improve pain control compared with a fixed-rate pump for adults having elective surgeries.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 1170 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | December 30, 2025 |
| Main results expected | October 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT07361822 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 years old with ASA physical status I–III who are scheduled for elective mixed surgeries (for example thoracoscopic, laparoscopic, open spinal, or craniotomy) are the intended participants.
✕Probably not a fit
People with chronic pain syndromes, psychiatric disorders, severe cardiovascular/cerebrovascular/renal/hepatic dysfunction, or allergy to PCA medications are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial enrolls adults aged 18–65 undergoing elective mixed surgeries and compares two intravenous patient-controlled analgesia (PCA) modes: a traditional fixed-rate basal infusion and a variable-rate feedback infusion. Participants will be assigned to receive one of the two PCA modes postoperatively and their cumulative opioid consumption, pain scores, and opioid-related adverse events will be recorded. The hypothesis is that the variable-rate feedback mode can better match changing postoperative pain, reduce total opioid use, and lower side effects compared with fixed-rate delivery. Results aim to provide evidence to support more individualized and intelligent postoperative analgesia protocols.
Why it matters
Potential benefit: If successful, the variable-rate feedback approach could lower opioid exposure, improve pain control, and reduce side effects after surgery.
How similar studies have gone: Smaller trials and device studies of adaptive or feedback-controlled PCA have shown promise in reducing opioid use and improving pain, but large multicenter confirmation is limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China Recruiting
Study contacts
- Study coordinator: Fang Luo
- Email: 13611326978@163.com
- Phone: 13611326978
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.