## Protocol Section
### Identification Module
**NCT ID:** NCT06437886

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 2024-2323
#### Organization
**Class:** OTHER
**Full Name:** Chinese Academy of Medical Sciences, Fuwai Hospital
### Status Module
#### Completion Date
**Date:** 2024-07-22

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-07-22

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-22

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Chinese Academy of Medical Sciences, Fuwai Hospital

#### Responsible Party

**Investigator Affiliation:** Chinese Academy of Medical Sciences, Fuwai Hospital

**Investigator Full Name:** Yan Fuxia

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Cardiac Surgery Patients

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: pecto-intercostal fascial block and rectus sheath block

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

**Type:** EXPERIMENTAL

#### Arm Group 2

**Label:** high-dose opiod traditional anesthesia

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

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

**Description:** 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.

**Name:** pecto-intercostal fascial block and rectus sheath block

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** the global score of the 15-item Quality of Recovery (QoR-15) questionnaire

**Time Frame:** at 24 hours postoperatively

#### Secondary Outcomes

**Description:** Postoperatvie pain was evaluated using an 11-point visual analogue scale (VAS) (0 = no pain, 10 = worst pain possible).

**Measure:** QoR-15, postoperative pain assessment

**Time Frame:** QoR-15 at 72 hours, postoperative pain assessment at 24 hours and 72 hours.

### Eligibility Module

**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:

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

**Maximum Age:** 70 Years

**Minimum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** Fuwai hospital

### IPD Sharing Statement Module

**Description:** Data availuable by sending email to corresponding authors

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M7102

- Name: Dexamethasone

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M1700

- Name: Ropivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
