High-dose Opioid Versus Opioid-sparing Anaesthesia in Cardiac Surgery

Not Applicable

• Conditions: Cardiac Surgery Patients
• Interventions: Other: opioid-sparing protocol

• Registration Number: NCT06437886
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-22
• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-05-31
• Status Verified: 2024-07
• Primary Completion: 2024-07-22
• Study Completion: 2024-07-22
• Last Update Submitted: 2024-07-27
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pecto-intercostal fascial block and rectus sheath block-based opioid-sparing anesthesia	opioid-sparing protocol	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number rating score (NRS)	NRS at 24 hours and 72 hours after surgery	Postoperatvie pain was evaluated using a number rating score (NRS) (0 = no pain, 10 = worst pain possible).
postoperative adverse events	during hospitalization, an average of 2 weeks, assessed up to 30 days	postoperative adverse events included major adverse cardiovascular events (MACCEs), moderate to severe acute kidney injury (AKI), moderate to severe acute liver injury, reintubation, and postoperative nausea and vomiting (PONV).
chronic pain	at 3 months after surgery	persistent postoperative pain lasting beyond 3 months
QoR-15 at 72h	QoR-15 at 72 hours after surgery	the global score of the 15-item Quality of Recovery (QoR-15) questionnaire at 72h after surgery

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, China