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

NCT ID: NCT06312904

Last Updated: 2025-02-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2024-08-14

Brief Summary

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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

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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paravertebral block group

This group of patients will undergo postoperative paravertebral block.

Group Type EXPERIMENTAL

paravertebral block

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Local infiltration anesthesia

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Local infiltration anesthesia

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jingfei Guo

Attending Physician, Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

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.

Reference Type DERIVED
PMID: 39510785 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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2023-GSP-QN-7

Identifier Type: -

Identifier Source: org_study_id

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