ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-25

Study Completion Date

2023-03-23

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.

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Detailed Description

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Conditions

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Nerve Block Analgesia Pectus Excavatum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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ESPB group

0.25% ropivacaine 0.5 ml/kg is injected at the fascial plane deep to the erector spinae muscle

Group Type EXPERIMENTAL

ESPB group

Intervention Type PROCEDURE

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.

TPVB group

0.25% ropivacaine 0.5 ml/kg is injected into the thoracic paravertebral space (T5) using TPVB approach.

Group Type ACTIVE_COMPARATOR

TPVB group

Intervention Type PROCEDURE

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.

Interventions

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ESPB group

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.

Intervention Type PROCEDURE

TPVB group

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.

Intervention Type PROCEDURE

Other Intervention Names

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Erector spinae plane block Thoracic paravertebral block

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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No