Clinical trial NCT06437886: High-dose Opioid Versus Opioid-sparing Anaesthesia in Cardiac Surgery
Official title: Postoperative Recovery After Cardiac Surgery A Randomised Controlled Trial of High-dose Opioid Versus Opioid-sparing Anaesthesia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cardiac Surgery Patients
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: QoR-15 at 24h
timeFrame: at 24 hours after surgery
Secondary outcomes:
measure: QoR-15 at 72h
timeFrame: QoR-15 at 72 hours after surgery
measure: Number rating score (NRS)
timeFrame: NRS at 24 hours and 72 hours after surgery
measure: postoperative adverse events
timeFrame: during hospitalization, an average of 2 weeks, assessed up to 30 days
measure: chronic pain
timeFrame: at 3 months after surgery
Other outcomes:
measure: Postoperative mechanical ventilation
timeFrame: The time from the end of operation to the removal of tracheal intubation, assessed up to 30 days
measure: hospital length of stay (LOS)
timeFrame: From the date of admission until the date of discharging, assessed up to 30 days
measure: hospital costs
timeFrame: during hospitalization, an average of 2 weeks, assessed up to 30 days
Locations:
city: Beijing
country: China
facility: Fuwai hospital
Study officials:
References: