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

Chinese Academy of Medical Sciences, Fuwai Hospital1 site in 1 country100 target enrollmentMarch 11, 2024

ConditionsPostoperative Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Postoperative Pain
Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Enrollment: 100
Locations: 1
Primary Endpoint: opioid consumption during the first 24h after surgery
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 11, 2024

End Date

August 14, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Responsible Party

Principal Investigator

Jingfei Guo

Attending Physician, Department of Anesthesiology

Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

opioid consumption during the first 24h after surgery

Time Frame: 24 hours postoperatively

the total amount of sufentanil and other opioids will be calculated as morphine equivalent dose (MED) divided by body weight

Secondary Outcomes

The rate of opioid treatment for remedial analgesia between groups(24 hours postoperatively)
FPS-R scale recorded at 6, 12, 18 and 24h postoperatively(24 hours postoperatively)