ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure

Study Overview
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Brief Summary
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This is a prospective randomized double-blind non-inferiority trial designed to test the hypothesis that erector spinae plane block (ESPB) is non-inferior to thoracic paravertebral block (TPVB) in postoperative pain control after pectus excavatum repair.

Official Title
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Comparison of Erector Spinae Plane and Paravertebral Nerve Blocks for Postoperative Analgesia in Children After the Nuss Procedure

Conditions
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Nerve Block, Analgesia, Pectus Excavatum

Intervention / Treatment
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* Procedure: ESPB group
* Procedure: TPVB group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 4 to 18 years Scheduled for elective Nuss surgery Written informed consent is obtained from parents of each patient. Exclusion Criteria: Coagulation dysfunction. American Society of Anesthesiologists Physical Status 4 or 5. Allergy to study medication. Local infection at the site of injection or systemic infection. Inability to understand Chinese.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESPB group<br>0.25% ropivacaine 0.5 ml/kg is injected at the fascial plane deep to the erector spinae muscle | Procedure: ESPB group<br>* A 21-gauge 100-mm needle will be inserted into the fascial layer beneath the iliocostalis, longissimus, and spinalis muscles. A bolus of 0.25% ropivacaine 0.5 ml/kg will be injected into the fascial layer. Contralateral ESPB will be performed similarly.<br>* Other names: Erector spinae plane block;|
| Active Comparator: TPVB group<br>0.25% ropivacaine 0.5 ml/kg is injected into the thoracic paravertebral space (T5) using TPVB approach. | Procedure: TPVB group<br>* A 21-gauge 100-mm insulated needle will be inserted into the paravertebral space via an in-plane parasagittal approach. After perforating the costotransverse ligament, 0.25% ropivacaine 0.5 ml/kg will be injected. Anterior movement of the pleura indicated the appropriate spread of the local anesthetics in the paravertebral space. The process will be repeated on the contralateral side.<br>* Other names: Thoracic paravertebral block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores at rest at 24 hours postoperatively | Pain scores will be recorded using the Numeric Rating Scale (NRS) scores (0-10). | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain degree at rest and after movement or coughing(dynamic) | The pain degree at rest and after movement or coughing at 3, 6, 12, 24, and 48 hours after surgery respectively. | at 3, 6, 12, 24, and 48 hours after surgery | 
| total rescue morphine-equivalent consumption per weight | total rescue morphine-equivalent consumption per weight at predetermined time intervals (24 and 48 hours) after surgery | at 24 and 48 hours after surgery | 
| Emergence agitation at 5, 15, 30 min after extubation | Emergence agitation will be registered using pediatric anesthesia emergence delirium (PAED) at 5, 15, 30 min after extubation | at 5, 15, 30 min after extubation | 
| Total dosage of intraoperative sufentanil and remifentanil | Total dosage of intraoperative sufentanil and remifentanil per weight | during surgery | 
| The time to first analgesia request | Time from operation to first rescue analgesia request | within the 3 days after surgery | 
| The time to first mobilization | Time from operation to ambulation | within the 3 days after surgery | 
| Side effects | Side effects such as pneumothorax, local anesthetic toxicity, postoperative nausea and vomiting | within the 5 days after surgery |