Clinical trial NCT06312904: Paravertebral Block for Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With CBP
Official title: Effects of Paravertebral Block on Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With Cardiopulmonary Bypass: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative analgesia
paravertebral block
pediatric cardiac surgery
enhanced recovery after surgery
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: opioid consumption during the first 24h after surgery
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: FPS-R scale recorded at 6, 12, 18 and 24h postoperatively
timeFrame: 24 hours postoperatively
measure: The rate of opioid treatment for remedial analgesia between groups
timeFrame: 24 hours postoperatively
Other outcomes:
measure: Length of postoperative mechanical ventilation
timeFrame: through study completion, an average of 2 weeks
measure: Length of ICU/hospital stay
timeFrame: through study completion, an average of 2 weeks
measure: The incidence of respiratory depression
timeFrame: through study completion, an average of 2 weeks
measure: The rate of postoperative nausea and vomiting (PONV) during the 24h postoperatively
timeFrame: through study completion, an average of 2 weeks
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases
name: Jingfei Guo
role: STUDY_CHAIR
References: