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

Cardiac Surgery Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06437886
• Other study ID #: 2024-2323
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: July 22, 2024

Study information

• Verified date: April 2024
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

BACKGROUND In cardiac surgery, high-dose opioids contributes to adverse events associated with poor postoperative outcomes. There is growing evidence that nerve block-based opioid-sparing protocols may reduce perioperative opioid consumption with equally analgesia management and consequently improve patient's postoperative recovery.

OBJECTIVE To determine whether opioid-sparing anaesthesia based on pecto-intercostal fascial block and rectus sheath block (PIFB and RSB) could improve early postoperative recovery after cardiac surgery.

DESIGN A randomised controlled trial. SETTING A tertiary hospital. PATIENTS Eighty 45-70 years old patients undergoing cardiac surgery were enrolled. Key exclusion criteria included extubation failure within 24 hours postoperatively, 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 PIFB and RSB-based opioid-sapring anaesthesia (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 24 h after surgery. Secondary outcomes included recovery-related time, postoperative pain score and rescue analgesia, health-related quality of life, the incidence of postoperative adeverse events and chronic pain.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: July 22, 2024
• Est. primary completion date: July 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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:

Patients with severe pulmonary, liver or renal dysfunction, contraindications to punctral or local anesthetic drugs, and inablity to communicate or refuse to enrollment.

Related Conditions & MeSH terms

• Cardiac Surgery Patients

Intervention

Other:
• pecto-intercostal fascial block and rectus sheath block
Bilateral PIFB and RSB was conducted after anesthetic induction in a supine position guided by ultrasound guidance. PIFB was conducted at the T2 to T5 levels under ultrasound guidance. The needle was inserted into the pecto-interfacial plane using an in-plane approach. Needle tip location was verified by ventral movement of the parietal pleura upon injection of 1-2 ml 0.9% saline. 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. Needle tip location was verified by ventral movement of the parietal pleura upon injection of 1-2 ml 0.9% saline. After verifying needle placement, 15 ml 0.3% ropivacaine containing 2.5 mg dexamethasone was delivered to each side.

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the global score of the 15-item Quality of Recovery (QoR-15) questionnaire		at 24 hours postoperatively
Secondary	QoR-15, postoperative pain assessment	Postoperatvie pain was evaluated using an 11-point visual analogue scale (VAS) (0 = no pain, 10 = worst pain possible).	QoR-15 at 72 hours, postoperative pain assessment at 24 hours and 72 hours.