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
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Cumulative opioid consumption
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Fixed-rate basal infusion mode group
Intervention: Fixed-rate basal infusion mode (Procedure)
time-programmed decremental background infusion mode group
Intervention: Time-programmed decremental background infusion mode (Procedure)
Outcomes
Primary Outcomes
Cumulative opioid consumption
Time Frame: Within the first 48 hours postoperatively
Cumulative opioid consumption
Time Frame: Within the first 24 hours postoperatively
Secondary Outcomes
- Bolus demand frequency(at 1, 6, 12, 24, and 48 hours postoperatively)
- Cumulative patient-controlled analgesia volume consumption(Within the first 48 hours postoperatively)
- Frequency of additional rescue analgesics(At 1, 6, 12, 24, and 48 hours postoperatively)
- Dosage of additional rescue analgesics(At 1, 6, 12, 24, and 48 hours postoperatively)
- The level of sedation and agitation(At 1, 6, 12, 24, and 48 hours postoperatively)
- The degree of nausea and vomiting(At 1, 6, 12, 24, and 48 hours postoperatively)
- The patient's satisfaction with patient-controlled analegsia device(At 48 hours postoperatively)
- 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)
- Quality of sleep(At 24, and 48 hours postoperatively)
- The level of sedation and agitation(At 12, and 24 hours postoperatively)
- The degree of nausea and vomiting(At 12, 24, and 48 hours postoperatively)
- The patient's satisfaction with patient-controlled analegsia device(At 24 hours postoperatively)
Investigators
Fang Luo
Director, Department of Pain Management, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital