Paravertebral Block for Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With CBP
NCT ID: NCT06312904
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2024-03-11
2024-08-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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paravertebral block group
This group of patients will undergo postoperative paravertebral block.
paravertebral block
After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct paravertebral block.
local infiltration group
This group of patients will undergo postoperative local infiltration anesthesia.
Local infiltration anesthesia
After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct local infiltration anesthesia.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
6 Years
14 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Responsible Party
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Jingfei Guo
Attending Physician, Department of Anesthesiology
Principal Investigators
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Jingfei Guo
Role: STUDY_CHAIR
Fuwai Hospital, National Center for Cardiovascular Diseases
Locations
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Fuwai Hospital, National Center for Cardiovascular Diseases
Beijing, , China
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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2023-GSP-QN-7
Identifier Type: -
Identifier Source: org_study_id
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