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CompletedNCT05034601Updated Nov 18, 2023

ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure

An interventional study of ESPB group and TPVB group in Nerve Block, Analgesia and Pectus Excavatum, sponsored by West China Hospital. Completed at 1 site in China. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by West China Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
4 Years to 18 Years
Sex
All
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Study summary

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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Conditions studied

  • Nerve Block
  • Analgesia
  • Pectus Excavatum

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In context

Funnel Chest

79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.

This study's enrollment of 68 is above the median of 40 across 46 interventional studies indexed under Funnel Chest.

Browse Funnel Chest studies →

Lead sponsor

West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 4 to 18 years Scheduled for elective Nuss surgery Written is obtained from parents of each patient.

Exclusion criteria

Exclusion Criteria:

  • Coagulation dysfunction. Physical Status 4 or 5. Allergy to study medication. Local infection at the site of injection or systemic infection. Inability to understand Chinese.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    ESPB group

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

    Procedure: ESPB group

  • Active comparator
    TPVB group

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

    Procedure: TPVB group

Interventions

  • ProcedureESPB 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.

    Also known as: Erector spinae plane block

  • ProcedureTPVB 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.

    Also known as: Thoracic paravertebral block

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What researchers measure

Primary outcomes

  1. Pain scores at rest at 24 hours postoperatively

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

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. 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.

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

  2. total rescue morphine-equivalent consumption per weight

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

    Time frame: at 24 and 48 hours after surgery

  3. 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

    Time frame: at 5, 15, 30 min after extubation

  4. Total dosage of intraoperative sufentanil and remifentanil

    Total dosage of intraoperative sufentanil and remifentanil per weight

    Time frame: during surgery

  5. The time to first analgesia request

    Time from operation to first rescue analgesia request

    Time frame: within the 3 days after surgery

  6. The time to first mobilization

    Time from operation to ambulation

    Time frame: within the 3 days after surgery

  7. Side effects

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

    Time frame: within the 5 days after surgery

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Study locations

1 site
  • Department of Anesthesiology, West China Hospital
    Chengdu, Sichuan 610041, China
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References and documents

Publications

  • Xu M, Zhang G, Gong J, Yang J. Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial. Trials. 2022 Feb 14;23(1):139. doi: 10.1186/s13063-022-06044-y. PubMed 35164831 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05034601
Responsible party
Min Xu (Department of Anesthesiology, West China Hospital, Sichuan University, West China Hospital) — Principal investigator
First posted
Sep 5, 2021
Start date
Sep 25, 2021
Primary completion
Mar 23, 2023
Completion
Mar 23, 2023
Last update
Nov 18, 2023

Study contacts

Jin Liu
study chair · Department of Anesthesiology, West China Hospital, Sichuan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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