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NCT Number: NCT06437886

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

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.

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Key information

Conditions

Cardiac Surgery Patients

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

opioid-sparing protocol

Other

Patients in the OSA group was administrated with 0.5 to 1 mcg·kg-1 sufentanil and received PIFB combined with RSB after anesthetic induction. Patients in the control group were recommended to receive 2 to 3 mcg·kg-1 opioid-based sufentanil. PIFB was conducted at the T2 to T5 levels under ultrasound guidance. Each side received 20 ml 0.3% ropivacaine containing 2.5 mg dexamethasone. Bilateral RSB was conducted after the PIFB and the needle was inserted into the plane between the rectus abdominal muscle and its posterior sheath using an in-plane approach. After verifying needle placement, 15 ml 0.3% ropivacaine containing 2.5 mg dexamethasone was delivered to each side. In the control group, patients received no procedure and were administrated with traditional anesthetic protocol. Patients received continuous intravenous sufentanil (50 to 100 mg) and tropisetron (5 to 10 mg) at 2 ml·h-1 for the first 48 hours after surgery.

Primary outcomes

  1. 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

  1. QoR-15 at 72h

    Time frame: QoR-15 at 72 hours after surgery

    the global score of the 15-item Quality of Recovery (QoR-15) questionnaire at 72h after surgery

  2. Number rating score (NRS)

    Time frame: 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).

  3. postoperative adverse events

    Time frame: 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).

  4. chronic pain

    Time frame: at 3 months after surgery

    persistent postoperative pain lasting beyond 3 months

Other outcomes

  1. Postoperative mechanical ventilation

    Time frame: The time from the end of operation to the removal of tracheal intubation, assessed up to 30 days

    The time from the end of operation to the removal of tracheal intubation

  2. hospital length of stay (LOS)

    Time frame: From the date of admission until the date of discharging, assessed up to 30 days

    From the date of admission until the date of discharging

  3. hospital costs

    Time frame: during hospitalization, an average of 2 weeks, assessed up to 30 days

    Total cost of patients during hospitalization

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 31, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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