Paravertebral Block for Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With CBP

Effects of Paravertebral Block on Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With Cardiopulmonary Bypass: a Randomized Controlled Trial

This study aims to compare the effect of paravertebral block and local infiltration anesthesia on postoperative analgesia in children undergoing lateral incision cardiac surgery with cardiopulmonary bypass. The researchers hope to investigate whether children who undergo paravertebral block experience less postoperative pain, have fewer postoperative complications, and recover more quickly.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: paravertebral block; Procedure: Local infiltration anesthesia

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Fuwai Hospital, National Center for Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children aged 6-14 years old;
2. Children who have atrial septal defect or ventricular septal defect scheduled for lateral incision cardiac surgery with cardiopulmonary bypass;
3. Inform consent signed by the parent or legal guardian.

Exclusion Criteria:

1. Patients who were intubated, on mechanical circulatory support, or with intravenous inotropes before surgery;
2. Emergency surgery or redo cardiac surgery;
3. Body weight more than 50kg;
4. Diagnosed as severe pulmonary hypertension;
5. Left ventricular ejection fraction less than 45% in most recent echocardiography before surgery;
6. Allergic to ropivacaine or other regular anesthetics, analgesics or other medications regularly used in the study;
7. Preoperative platelet counts less than 100*109/L, coagulopathy or bleeding tendency ;
8. Preoperatively using antiplatelets or anticoagulants;
9. Diagnosed with scoliosis or other contraindications for PVB.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: paravertebral block group; This group of patients will undergo postoperative paravertebral block.	Procedure: paravertebral block; After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct paravertebral block.
Active Comparator: local infiltration group; This group of patients will undergo postoperative local infiltration anesthesia.	Procedure: Local infiltration anesthesia; After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct local infiltration anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption during the first 24h after surgery	the total amount of sufentanil and other opioids will be calculated as morphine equivalent dose (MED) divided by body weight	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FPS-R scale recorded at 6, 12, 18 and 24h postoperatively	The Faces Pain Scale-Revised (FPS-R) is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widely accepted 0-to-10 metric. The scale shows a close linear relationship with visual analog pain scales across the age range of 4-16 years. The bedside nurse will show the patients a picture of six faces, and score 0, 2, 4, 6, 8, and 10 from left to right. "0" equals "no pain" and "10" equals "very much pain." They will ask the patient to choose a face that represents their current pain condition and record the pain score.	24 hours postoperatively
The rate of opioid treatment for remedial analgesia between groups		24 hours postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of postoperative mechanical ventilation		through study completion, an average of 2 weeks
Length of ICU/hospital stay		through study completion, an average of 2 weeks
The incidence of respiratory depression	The respiratory depression is defined as: with no obvious upper respiratory tract obstruction: SpO2 < 90% and lasts for more than one minute, or respiratory rate < 8 times/min, or SpO2 < 94% and respiratory rate < 10 times/min, or supplemental oxygen is needed to maintain SpO2 > 94%.	through study completion, an average of 2 weeks
The rate of postoperative nausea and vomiting (PONV) during the 24h postoperatively		through study completion, an average of 2 weeks

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Investigators: Study Chair: Jingfei Guo, Fuwai Hospital, National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Actual): August 9, 2024
• Study Completion (Actual): August 14, 2024

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative analgesia; paravertebral block; pediatric cardiac surgery; enhanced recovery after surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2023-GSP-QN-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The original data will be published in 2025 on http://www.medresman.org.cn
• IPD Sharing Time Frame: 2025.1-2026.1
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No