Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07375121

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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