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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paravertebral block group | Experimental | This group of patients will undergo postoperative paravertebral block. |
|
| local infiltration group | Active Comparator | This group of patients will undergo postoperative local infiltration anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paravertebral block | Procedure | After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct paravertebral block. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jingfei Guo | Fuwai Hospital, National Center for Cardiovascular Diseases | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39510785 | Derived | 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. |
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The original data will be published in 2025 on http://www.medresman.org.cn
2025.1-2026.1
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 26, 2024 | Mar 8, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| Local infiltration anesthesia | Procedure | After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct local infiltration anesthesia. |
|
| 24 hours postoperatively |
| The rate of opioid treatment for remedial analgesia between groups | 24 hours postoperatively |
| 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 |
| The rate of postoperative nausea and vomiting (PONV) during the 24h postoperatively | through study completion, an average of 2 weeks |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |