Actively Recruiting
Prospective Randomized Controlled Study Comparing Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes of Intravenous Patient-Controlled Analgesia After Mixed Surgery
Led by Beijing Tiantan Hospital · Updated on 2026-05-14
1170
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
S
Shenzhen University General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Perioperative pain management plays a crucial role in patient recovery after surgery, yet many patients experience moderate to severe pain, which delays healing and raises complication risks. This research investigates different patient-controlled analgesia (PCA) strategies to manage pain better while aiming to reduce opioid use and related side effects. The study compares traditional fixed-rate PCA with a variable-rate feedback infusion mode to provide evidence for more personalized and adaptive pain control methods during postoperative care. Participants will receive a standardized PCA solution containing sufentanil, ondansetron, and saline. One group will use a fixed-rate basal infusion delivering a steady dose, while the other group will use a variable-rate feedback infusion that adjusts the opioid dose based on patient demand. The variable-rate allows increases or decreases in the background infusion depending on pain needs, with limits set for safety. This approach aims to improve pain relief while minimizing opioid consumption. Throughout the study, patients' opioid use will be closely monitored for 48 hours post-surgery. Pain levels at rest and movement, PCA usage volume, additional rescue medication needs, quality of recovery and sleep, sedation levels, nausea, and patient satisfaction will be assessed at various intervals within the first two days. The study uses a randomized, quadruple-blind design to ensure unbiased results and will provide detailed safety and effectiveness data to support improved postoperative pain management.
CONDITIONS
Brief Title
Comparison of Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes 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 thoracic, abdominal, spinal, orthopedic, or cranial procedures using minimally invasive or open approaches
You will not qualify if you...
- Allergy to patient-controlled analgesia (PCA) medications
- Presence of chronic pain syndromes
- Presence of psychiatric disorders
- Severe cardiovascular, cerebrovascular, renal, or hepatic dysfunction
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 - 48 hours postoperatively
Participants receive intravenous patient-controlled analgesia (PCA) using either a fixed-rate basal infusion mode or a variable-rate feedback infusion mode for postoperative pain management after mixed surgery.
Assessments at 1, 6, 12, 24, and 48 hours postoperatively
Duration - Up to 48 hours postoperatively
Participants are monitored for pain scores, opioid consumption, quality of recovery, sleep quality, sedation, nausea, and satisfaction with PCA during the 48-hour postoperative period.
Multiple assessments within 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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here