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

NCT07375121 | Recruiting DMC

• 1 other identifier: KY2025-387-02-2
• Study Type: interventional
• Target: 450
• 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)

• Cumulative opioid consumption

  Within the first 24 hours postoperatively

Secondary Outcomes (9)

• Resting and movement pain score was assessed by numeric rating scale.

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

• Cumulative patient-controlled analgesia volume consumption

  Within the first 24 hours postoperatively

• Frequency of additional rescue analgesics

  At 12, 24, and 48 hours postoperatively

• Dosage of additional rescue analgesics

  At 12, 24, and 48 hours postoperatively

• Postoperative quality of recovery

  At 24, and 48 hours postoperatively

Study Arms (2)

Fixed-rate basal infusion mode group

ACTIVE COMPARATOR

Procedure: Fixed-rate basal infusion mode

time-programmed decremental background infusion mode group

EXPERIMENTAL

Procedure: Time-programmed decremental background 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

Time-programmed decremental background infusion mode PROCEDURE

The PCA settings were based on the previous study. The rate, loading dose, and demand dose of the PCA pump were all calculated based on lean body weight: Lean body weight (kg) = 0.29569 \* body weight (kg) + 0.41813 \* height (cm) - 43.2933. Loading dose (mL) = lean body weight (kg) \* 0.1 mL. Demand dose (mL) = lean body weight (kg) \* 0.04 mL. Background infusion rate within 6 hours after surgery (mL/h) = lean body weight (kg) \* 0.1 mL/h. Background infusion rate from 6 to 24 hours after surgery (mL/h) = lean body weight (kg) \* 0.02 mL/h. Background infusion rate from 24 to 48 hours after surgery (mL/h) = lean body weight (kg) \* 0.01 mL/h.

time-programmed decremental background 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 thoracoscopic surgery, laparoscopic surgery, hysteroscopy surgery, laparotomy, thoracotomy, open spinal surgery, craniotomy, and so on.

You may not qualify if:

• Chronic pain syndromes;
• Psychiatric disorders;
• Severe cardiovascular or cerebrovascular disease, renal or hepatic functional dysfunction, or allergic to PCA medications.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

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

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

59976661; 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: January 13, 2026
• First Posted: January 29, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)