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

Official title

Prospective Randomized Controlled Study of Individualized PCA Model Based on Multi-dimensional Strategies (Fixed-rate Basal Infusion Mode and Time-programmed Decremental Background Infusion Mode)

Overview

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.

Detailed description

Perioperative pain management significantly impacts patient recovery outcomes. However, the incidence of moderate to severe postoperative pain remains high at 73.8%, which impedes recovery and increases complication risks. Although opioids serve as first-line analgesics, excessive use causes numerous adverse reactions. The traditional fixed-rate Patient-Controlled Analgesia (PCA) mode fails to adapt to dynamic postoperative pain variations. This study will compare different PCA optimization strategies, hypothesizing that these approaches can reduce opioid dosage, enhance analgesic effectiveness, and minimize adverse reactions. The research aims to provide evidence-based foundations for postoperative analgesia, promoting individualized and intelligent pain management systems that better serve patient needs throughout recovery.

Interventions

• Procedure Fixed-rate basal infusion mode
  All participants received a standardized PCA solution containing sufentanil (200 μg), ondansetron (32 mg), and normal saline with total volume 200 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.
• Procedure Time-programmed decremental background infusion mode
  In the time-programmed decremental infusion group, which served as the intervention group, the bolus dose and lockout interval will remain the same, whereas the background infusion rate will be reduced according to a predefined postoperative schedule designed to match the expected decline in postoperative pain intensity. Specifically, the background infusion rate will be set at 4.0 mL/h during the first 6 postoperative hours, reduced to 3 mL/h from 6 to 12 hours, decreased to 2.0 mL/h from 12 to

Primary outcome measures

• Cumulative opioid consumption [Time frame: Within the first 48 hours postoperatively]

Secondary outcome measures (10)

• Resting and movement pain score was assessed by numeric rating scale. [Time frame: At 1, 6, 12, 24, and 48 hours postoperatively]
• Cumulative patient-controlled analgesia volume consumption [Time frame: Within the first 48 hours postoperatively]
• Frequency of additional rescue analgesics [Time frame: At 1, 6, 12, 24, and 48 hours postoperatively]
• Dosage of additional rescue analgesics [Time frame: At 1, 6, 12, 24, and 48 hours postoperatively]
• Bolus demand frequency [Time frame: at 1, 6, 12, 24, and 48 hours postoperatively]
• Postoperative quality of recovery [Time frame: At 24, and 48 hours postoperatively]
• Quality of sleep [Time frame: At 24, and 48 hours postoperatively]
• The level of sedation and agitation [Time frame: At 1, 6, 12, 24, and 48 hours postoperatively]
• The degree of nausea and vomiting [Time frame: At 1, 6, 12, 24, and 48 hours postoperatively]
• The patient's satisfaction with patient-controlled analegsia device [Time frame: At 48 hours postoperatively]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing

Publications

• Ma Y, Liu M, Sun H, Luo F, Wan L. Comparison of Cumulative Opioid Consumption Between Time-Programmed Decremental Infusion and Fixed-Rate Basal Infusion Modes of Intravenous Patient-Controlled Analgesia Following Mixed Surgery: Protocol for a Randomized Controlled Trial. J Pain Res. 2026 Jun 4;19:613446. doi: 10.2147/JPR.S613446. eCollection 2026. PMID 42272993

Identifiers

NCT: NCT07375121 · KY2025-387-02-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗