Actively Recruiting
Comparison of Fixed-rate Basal Infusion and Time-programmed Decremental Background Infusion Modes for Intravenous Patient-Controlled Analgesia After Mixed Surgery
Led by Beijing Tiantan Hospital · Updated on 2026-04-06
450
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying pain management after surgery, focusing on how to improve recovery by controlling pain more effectively. Despite opioids being commonly used, many patients experience moderate to severe pain after surgery, which can slow recovery and increase complications. This study compares two different patient-controlled analgesia (PCA) methods to see if one can reduce opioid use, improve pain relief, and lower side effects. The goal is to support personalized and smarter pain management after surgery. Participants receive one of two PCA treatments using a standardized solution with sufentanil and ondansetron. One group gets a fixed-rate infusion delivering a steady dose continuously. The other group follows a time-programmed decreasing infusion, where the infusion rate reduces stepwise over 48 hours to match expected pain changes. Both groups can self-administer doses as needed with a lockout interval to limit overdose. During the first 48 hours after surgery, researchers will track total opioid use, pain levels at rest and during movement, and use of any extra pain medications. They will also assess patients' recovery quality, sleep, sedation, nausea, and satisfaction with the PCA device. These measures will be taken at multiple time points to monitor effects and safety. The study runs from surgery through the first two postoperative days to gather comprehensive data on pain control approaches.
CONDITIONS
Brief Title
Comparison of the Efficacy and Safety of Fixed-rate Basal Infusion Mode and Time-programmed Decremental Background Infusion Mode of Intravenous PCA Following Mixed Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 to 65 years
- American Society of Anesthesiologists physical status I to III
- Scheduled for elective mixed surgery including thoracoscopic, laparoscopic, hysteroscopic, laparotomy, thoracotomy, open spinal surgery, or craniotomy
You will not qualify if you...
- Chronic pain syndromes
- Psychiatric disorders
- Severe cardiovascular or cerebrovascular disease
- Renal or hepatic functional dysfunction
- Allergy to PCA medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours after surgery
Participants receive one of two intravenous patient-controlled analgesia (PCA) infusion modes following surgery to manage postoperative pain.
Assessments at 1, 6, 12, 24, and 48 hours postoperatively
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China
Actively Recruiting
Research Team
F
Fang Luo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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