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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Local infiltration anesthesia; Procedure: paravertebral block

• Registration Number: NCT06312904
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-03-08
• Study Start: 2024-03-11
• Study First Posted: 2024-03-15
• Primary Completion: 2024-08-09
• Study Completion: 2024-08-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
local infiltration group	Local infiltration anesthesia	This group of patients will undergo postoperative local infiltration anesthesia.
paravertebral block group	paravertebral block	This group of patients will undergo postoperative paravertebral block.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Fuwai Hospital, National Center for Cardiovascular Diseases; 🇨🇳 Beijing, China