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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Allergy to PCA medications;

Presence of chronic pain syndromes;

Presence of psychiatric disorders, or severe cardiovascular, cerebrovascular, renal, or hepatic dysfunction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fixed-rate basal infusion mode

    Procedure/Surgery

    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.

  • Variable-rate feedback infusion mode

    Procedure/Surgery

    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.

Treatment groups

1,170 Participants
are divided into 2 treatment groups
Group A: Fixed-rate basal infusion mode groupActive comparator 1 intervention
Group B: Variable-rate feedback infusion mode groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total cumulative opioid consumption

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

Time frame
at 48 hours postoperatively

Secondary outcomes

1

Resting and movement pain score was assessed by NRS

NRS ranges from 0 to 10, with the highest score indicating the worst pain.

Time frame
At 1, 6, 12, 24, and 48 hours postoperatively
2

Cumulative PCA volume consumption

Time frame
Within the first 48 hours postoperatively
3

Number of additional rescue analgesics

Time frame
within 48 hours postoperatively
4

Dosage of additional rescue analgesics

Time frame
within 48 hours postoperatively

Other outcomes

Sponsors and contacts

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Beijing Tiantan Hospital

Lead sponsor

The Second Affiliated Hospital of Hainan Medical University

Collaborator

Youjiang Medical College for Nationalities

Collaborator