Comparison of Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes of Intravenous PCA Following Mixed Surgery

NCT07361822 | Recruiting DMC

• 1 other identifier: KY2025-387-02-1
• Study Type: interventional
• Target: 1,170
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative pain management affects patient recovery. However, the rate of moderate to severe postoperative pain is as high as 73.8%, which hinders recovery and increases the risk of complications. Although opioids are the first-line analgesics, excessive use leads to adverse reactions. The traditional fixed-rate PCA mode is difficult to match the changes in postoperative pain. This study will compare different PCA mode optimization strategies, assuming that they can reduce opioid dosage, improve analgesic effect, and reduce adverse reactions, providing high-quality evidence-based basis for postoperative analgesia and promoting individualized and intelligent management.

Conditions

Surgery; Pain Management; Opioid Consumption; Patient-controlled Analgesia

Outcome Measures

Primary Outcomes (1)

• Total cumulative opioid consumption

  The total cumulative opioid consumption includes sufentanil delivered via PCA and opioid-equivalent rescue analgesics.

  at 48 hours postoperatively

Secondary Outcomes (9)

• Resting and movement pain score was assessed by NRS

  At 1, 6, 12, 24, and 48 hours postoperatively

• Cumulative PCA volume consumption

  Within the first 48 hours postoperatively

• Number of additional rescue analgesics

  within 48 hours postoperatively

• Dosage of additional rescue analgesics

  within 48 hours postoperatively

• Postoperative quality of recovery

  At 24 hours postoperatively

Study Arms (2)

Fixed-rate basal infusion mode group

ACTIVE COMPARATOR

Procedure: Fixed-rate basal infusion mode

Variable-rate feedback infusion mode group

EXPERIMENTAL

Procedure: Variable-rate feedback infusion mode

Interventions

Fixed-rate basal infusion mode PROCEDURE

All participants received a standardized PCA solution containing sufentanil (100 μg), ondansetron (16 mg), and normal saline with total volume 100 mL. In conventional fixed-rate basal infusion mode group, the PCA was set to administer a bolus of 2 mL with a lock out interval of 15 minutes and background infusion rate 2 mL/h.

Fixed-rate basal infusion mode group

Variable-rate feedback infusion mode PROCEDURE

All participants received a standardized PCA solution containing sufentanil (100 μg), ondansetron (16 mg), and normal saline with total volume 100 mL. In variable-rate feedback infusion mode group, a bolus of 2 mL with a lock out interval of 15 minutes and background infusion rate 2 mL/h, which increased to 2.5 mL/h, was used whenever the demand dose was administered within lock out interval. The background infusion rate automatically decreased by 0.5 mL/h when the bolus button was not pressed for 1 hour. The background infusion rate was limited to a maximum of 12.0 mL/h and a minimum of 1 mL/h. The specific variable-rate feedback infusion mode setting was based on previous research, and the opinions of manufacturers and researchers to ensure patient safety and to provide effective analgesia.

Variable-rate feedback infusion mode group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 18 to 65 years;
• American Society of Anesthesiologists physical status Ⅰ - Ⅲ;
• Patients scheduled for elective mixed surgery were enrolled. Mixed surgeries included thoracic, abdominal, spinal, orthopaedic, and cranial procedures performed using either minimally invasive or open approaches.

You may not qualify if:

• Allergy to PCA medications;
• Presence of chronic pain syndromes;
• Presence of psychiatric disorders, or severe cardiovascular, cerebrovascular, renal, or hepatic dysfunction.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Youjiang Medical College for Nationalities: collaborator
• The Second Affiliated Hospital of Hainan Medical University: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

RECRUITING

Related Links

• Mitra S, Carlyle D, Kodumudi G, Kodumudi V, Vadivelu N. New Advances in Acute Postoperative Pain Management. Curr Pain Headache Rep. 2018;22(5):35.
• Momeni M, Crucitti M, De Kock M. Patient-controlled analgesia in the management of postoperative pain. Drugs. 2006;66(18):2321-37.
• Jung KT, So KY, Kim SU, Kim SH. The Optimizing Background Infusion Mode Decreases Intravenous Patient-Controlled Analgesic Volume and Opioid Consumption Compared to Fixed-Rate Background Infusion in Patients Undergoing Laparoscopic Cholecystectomy: A Pro

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fang Luo

CONTACT

13611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Pain Management, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 23, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)