Comparing fixed-rate versus time-programmed decreasing IV PCA after surgery

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)

This trial will try two different IV patient-controlled analgesia infusion methods to see which reduces opioid use and improves pain control for adults after elective mixed surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07375121 on ClinicalTrials.gov

What this trial studies

Adults having elective mixed surgery will receive intravenous patient-controlled analgesia programmed either as a fixed-rate basal infusion or as a time-programmed decremental background infusion. The study will compare total opioid consumption, postoperative pain scores, and the incidence of opioid-related adverse events between the two infusion modes. Patients aged 18–65 with ASA physical status I–III who meet eligibility criteria will be enrolled at Beijing Tiantan Hospital and assigned to one of the two PCA strategies. Results are intended to support more individualized and time-adaptive postoperative pain management.

Who should consider this trial

Good fit: Adults aged 18–65 with ASA physical status I–III who are scheduled for elective mixed surgeries (for example thoracoscopic, laparoscopic, hysteroscopic, laparotomy, thoracotomy, open spinal surgery, or craniotomy) are ideal candidates.

Not a fit: Patients with chronic pain syndromes, psychiatric disorders, severe cardiac/cerebrovascular disease, significant renal or hepatic dysfunction, or allergies to PCA medications are unlikely to benefit or be eligible for this protocol.

Why it matters

Potential benefit: If successful, the optimized PCA mode could lower opioid doses, improve postoperative pain relief, and reduce opioid-related side effects.

How similar studies have performed: Related PCA optimization approaches have been tested in smaller studies with some promise in reducing opioid use and side effects, but evidence is mixed and not yet widely adopted.

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:

* Chronic pain syndromes;
* Psychiatric disorders;
* Severe cardiovascular or cerebrovascular disease, renal or hepatic functional dysfunction, or allergic to PCA medications.

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