Skip to main content
OpenTrials
Completed

NCT Number: NCT06312904

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital, National Center for Cardiovascular Diseases

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

paravertebral block

Procedure

After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct paravertebral block.

Local infiltration anesthesia

Procedure

After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct local infiltration anesthesia.

Primary outcomes

  1. 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

  1. FPS-R scale recorded at 6, 12, 18 and 24h postoperatively

    Time frame: 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.

  2. The rate of opioid treatment for remedial analgesia between groups

    Time frame: 24 hours postoperatively

Other outcomes

  1. Length of postoperative mechanical ventilation

    Time frame: through study completion, an average of 2 weeks

  2. Length of ICU/hospital stay

    Time frame: through study completion, an average of 2 weeks

  3. The incidence of respiratory depression

    Time frame: through study completion, an average of 2 weeks

    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%.

  4. The rate of postoperative nausea and vomiting (PONV) during the 24h postoperatively

    Time frame: through study completion, an average of 2 weeks

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.