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

NCT ID: NCT06437886

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2024-07-22

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.

Conditions

Cardiac Surgery Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

pecto-intercostal fascial block and rectus sheath block-based opioid-sparing anesthesia

Group Type: EXPERIMENTAL

opioid-sparing protocol

Intervention Type: 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.

high-dose opiod traditional anesthesia

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

opioid-sparing protocol

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yan Fuxia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fuwai hospital

Beijing, , China

Countries

China

Other Identifiers

2024-2323

Identifier Type: -

Identifier Source: org_study_id