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The Analgesic Effect and Recovery Quality of Patient-Controlled Analgesia with Variable-Rate Feedback Infusion Mode in Patients Undergoing Gynecologic Laparoscopic Tumor Surgery: A Randomized Controlled Trial

The Analgesic Effect and Recovery Quality of Patient-Controlled Analgesia with Variable-Rate Feedback Infusion Mode in Patients Undergoing Gynecologic Laparoscopic Tumor Surgery: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124586
Enrollment
Unknown
Registered
2026-05-14
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative acute pain

Interventions

VFIM-PCA group:Variable-rate Feedback Infusion Mode PCA
TBIM-PCA group:Traditional Background Infusion Mode PCA

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age 18–65 years; 2.Body Mass Index (BMI): 18–30 kg/m^2; 3.ASA Physical Status Classification: I–III; 4.Estimated surgical duration less than 5 hours; 5.Scheduled for elective laparoscopic radical surgery for gynecological tumors; 6.No history of previous lower abdominal surgery; 7.Agreement to use Patient-Controlled Intravenous Analgesia (PCIA) postoperatively; 8.The patient and their family members voluntarily agree to participate and have provided written informed consent;

Exclusion criteria

Exclusion criteria: 1.Patients allergic or contraindicated to the investigational drug; 2.Patients with a history of alcohol, sedative-analgesic drugs, psychotropic substances, or drug abuse or addiction; 3.Patients with severe preoperative neurological or psychiatric disorders, language barriers, or other conditions that hinder communication or cooperation; 4.Patients deemed by the investigator to have severe cardiovascular, pulmonary, renal, or hepatic diseases; 5.Patients with preoperative cognitive impairment.

Design outcomes

Primary

MeasureTime frame
Postoperative 24-hour opioid consumption;

Secondary

MeasureTime frame
Effect of pain on mobility at 24 and 48 hours postoperatively;Postoperative 24-hour opioid consumption;Effect of pain on emotional state at 24 and 48 hours postoperatively.;Sleep scores (NRS) at 24 hours, 48 hours, 3 days, 5 days, and 7 days postoperatively;Total amount of rescue analgesics consumed at 24 and 48 hours postoperatively;Postoperative adverse events (nausea, vomiting, dizziness, etc.) at 24 hours, 48 hours, 3 days, 5 days, and 7 days after surgery.;Effect of pain on sleep at 24 and 48 hours postoperatively;Quality of recovery at 24 hours, 48 hours, 3 days, 5 days, and 7 days postoperatively;Feeding tolerance assessment at 24h, 48h, day 3, day 5, and day 7 postoperatively;The lowest and worst pain scores experienced within the first 24 and 48 hours after surgery.;Anxiety and depression scores at 24 hours, 48 hours, 3 days, 5 days, and 7 days postoperatively;

Countries

China

Contacts

Public ContactYingying Zhao

The First Affiliated Hospital of Zhengzhou University

zyy260340@163.com+86 13733198879

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026