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

NCT06312904 | Completed

• 1 other identifier: 2023-GSP-QN-7
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Postoperative analgesia; paravertebral block; pediatric cardiac surgery; enhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  24 hours postoperatively

• The rate of opioid treatment for remedial analgesia between groups

  24 hours postoperatively

Other Outcomes (4)

• Length of postoperative mechanical ventilation

  through study completion, an average of 2 weeks

• Length of ICU/hospital stay

  through study completion, an average of 2 weeks

• The incidence of respiratory depression

  through study completion, an average of 2 weeks

Study Arms (2)

paravertebral block group

EXPERIMENTAL

This group of patients will undergo postoperative paravertebral block.

Procedure: paravertebral block

local infiltration group

ACTIVE COMPARATOR

This group of patients will undergo postoperative local infiltration anesthesia.

Procedure: Local infiltration anesthesia

Interventions

paravertebral block PROCEDURE

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

paravertebral block group

Local infiltration anesthesia PROCEDURE

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

local infiltration group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases

Beijing, China

Location

Related Publications (1)

• Guo J, Tian L, Kang W, Jia Y, Yuan S. Effects of paravertebral block on postoperative analgesia in children undergoing unilateral thoracotomy cardiac surgery with cardiopulmonary bypass: protocol for a randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e086462. doi: 10.1136/bmjopen-2024-086462.

  PMID: 39510785 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Jingfei Guo

  Fuwai Hospital, National Center for Cardiovascular Diseases

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Anesthesiology

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 15, 2024
• Study Start: March 11, 2024
• Primary Completion: August 9, 2024
• Study Completion: August 14, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2025.1-2026.1

Locations

CN (1)