Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07361822

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

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 thoracic, abdominal, spinal, orthopedic, or cranial procedures using minimally invasive or open approaches
Not Eligible

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

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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 - 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

Follow-up

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

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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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Frequently Asked Questions

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