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

NCT06437886 | Enrolling By Invitation

• 1 other identifier: 2024-2323
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• QoR-15 at 24h

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

  at 24 hours after surgery

Secondary Outcomes (4)

• QoR-15 at 72h

  QoR-15 at 72 hours after surgery

• 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

Other Outcomes (3)

• Postoperative mechanical ventilation

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

• hospital length of stay (LOS)

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

• hospital costs

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

Study Arms (2)

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

EXPERIMENTAL

Other: opioid-sparing protocol

high-dose opiod traditional anesthesia

NO INTERVENTION

Interventions

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.

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

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Fuwai hospital

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 31, 2024
• Study Start: April 22, 2024
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)