Comparing adjustable feedback IV patient-controlled pain pumps with fixed-rate pumps after surgery.

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)

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 426 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07361822 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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

Exclusion Criteria:

* Allergy to PCA medications;
* Presence of chronic pain syndromes;
* Presence of psychiatric disorders, or severe cardiovascular, cerebrovascular, renal, or hepatic dysfunction.

Where this trial is running

Beijing

• Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Fang Luo

Conditions Surgery; Pain Management; Opioid Consumption; Patient-controlled Analgesia