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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06312904
• Other study ID #: 2023-GSP-QN-7
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Jingfei Guo, MD
• Phone: 15810396387
• Email: trhsbcq[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• paravertebral block
After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct paravertebral block.
• Local infiltration anesthesia
After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct local infiltration anesthesia.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of postoperative mechanical ventilation		through study completion, an average of 2 weeks
Other	Length of ICU/hospital stay		through study completion, an average of 2 weeks
Other	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
Other	The rate of postoperative nausea and vomiting (PONV) during the 24h postoperatively		through study completion, an average of 2 weeks
Primary	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	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
Secondary	The rate of opioid treatment for remedial analgesia between groups		24 hours postoperatively