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Completed

NCT Number: NCT05034601

ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure

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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Key information

Conditions

Nerve Block Agnosia Analgesia Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pectus Excavatum Perceptual Disorders Signs and Symptoms

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, West China Hospital

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESPB group

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.

Other names: Erector spinae plane block

TPVB group

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.

Other names: Thoracic paravertebral block

Primary outcomes

  1. Pain scores at rest at 24 hours postoperatively

    Time frame: 24 hours postoperatively

    Pain scores will be recorded using the Numeric Rating Scale (NRS) scores (0-10).

Secondary outcomes

  1. The pain degree at rest and after movement or coughing(dynamic)

    Time frame: at 3, 6, 12, 24, and 48 hours after surgery

    The pain degree at rest and after movement or coughing at 3, 6, 12, 24, and 48 hours after surgery respectively.

  2. total rescue morphine-equivalent consumption per weight

    Time frame: at 24 and 48 hours after surgery

    total rescue morphine-equivalent consumption per weight at predetermined time intervals (24 and 48 hours) after surgery

  3. Emergence agitation at 5, 15, 30 min after extubation

    Time frame: 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

  4. Total dosage of intraoperative sufentanil and remifentanil

    Time frame: during surgery

    Total dosage of intraoperative sufentanil and remifentanil per weight

  5. The time to first analgesia request

    Time frame: within the 3 days after surgery

    Time from operation to first rescue analgesia request

  6. The time to first mobilization

    Time frame: within the 3 days after surgery

    Time from operation to ambulation

  7. Side effects

    Time frame: within the 5 days after surgery

    Side effects such as pneumothorax, local anesthetic toxicity, postoperative nausea and vomiting

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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