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Clinical Trials/NCT06437886
NCT06437886
Enrolling By Invitation
Not Applicable

Postoperative Recovery After Cardiac Surgery A Randomised Controlled Trial of High-dose Opioid Versus Opioid-sparing Anaesthesia

Chinese Academy of Medical Sciences, Fuwai Hospital1 site in 1 country80 target enrollmentApril 22, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgery Patients
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Enrollment
80
Locations
1
Primary Endpoint
QoR-15 at 24h
Status
Enrolling By Invitation
Last Updated
last year

Overview

Brief Summary

BACKGROUND In cardiac surgery, high-dose opioid contributes to adverse events associated with poor postoperative outcomes. There is growing evidence that nerve block-based multi-modal anesthesia protocols may reduce intraoperative opioid consumption without compromising analgesia management and consequently improve patient's early postoperative recovery.

OBJECTIVE To determine whether opioid-sparing anaesthesia based on ultrasound-guided nerve block could improve early postoperative recovery after cardiac surgery.

DESIGN A randomised controlled trial. SETTING A tertiary hospital. PATIENTS Eighty patients aged 45 to 70 years undergoing cardiac surgery were enrolled. Key exclusion criteria included contraindication to interventions or drugs and a history of chronic pain or chronic opioid use.

INTERVENTIONS Eligible patients were randomised at a 1:1 ratio to receive either opioid-sparing anaesthesia based on ultrasound-guided nerve block (intervention group) or opioid-based anaesthesia (control group).

MAIN OUTCOME MEASURES The primary outcome was the global score of the 15-item Quality of Recovery (QoR-15) questionnaire at 24h after surgery. Secondary outcomes included QoR-15 at 72h after surgery, postoperative pain score, the incidence of postoperative adverse events and chronic pain. Other outcomes included endotracheal intubation duration, length of hospitalization, and hospital costs.

Registry
clinicaltrials.gov
Start Date
April 22, 2024
End Date
July 22, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yan Fuxia

Principal Investigator

Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility Criteria

Inclusion Criteria

  • Male or female adult patients aged 45 to 70 years, awaiting elective cardiac surgery, and American Society of Anaesthesiologists physical status classes II or III were eligible.

Exclusion Criteria

  • contraindications to punctual or local anesthetic drugs, a history of chronic pain or chronic opioid use, and an inability to communicate or refuse to enroll.

Outcomes

Primary Outcomes

QoR-15 at 24h

Time Frame: at 24 hours after surgery

the global score of the 15-item Quality of Recovery (QoR-15) questionnaire at 24h after surgery

Secondary Outcomes

  • Number rating score (NRS)(NRS at 24 hours and 72 hours after surgery)
  • postoperative adverse events(during hospitalization, an average of 2 weeks, assessed up to 30 days)
  • chronic pain(at 3 months after surgery)
  • QoR-15 at 72h(QoR-15 at 72 hours after surgery)

Study Sites (1)

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