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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

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Capital Medical University

Status

Enrolling

Conditions

Surgery
Pain Management
Opioid Consumption
Patient Controlled Analgesia

Treatments

Procedure: Time-programmed decremental background infusion mode
Procedure: Fixed-rate basal infusion mode

Study type

Interventional

Funder types

Other

Identifiers

NCT07375121
KY2025-387-02-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

450 participants in 2 patient groups

Fixed-rate basal infusion mode group
Active Comparator group
Treatment:
Procedure: Fixed-rate basal infusion mode
time-programmed decremental background infusion mode group
Experimental group
Treatment:
Procedure: Time-programmed decremental background infusion mode

Trial contacts and locations

1

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Central trial contact

Fang Luo

Data sourced from clinicaltrials.gov

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