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ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure

Sponsor
West China Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05034601
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
11.2
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ESPB group
  • Procedure: TPVB group
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Comparison of Erector Spinae Plane and Paravertebral Nerve Blocks for Postoperative Analgesia in Children After the Nuss Procedure
Actual Study Start Date :
Sep 25, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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

    		•
    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
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain scores at rest at 24 hours postoperatively [24 hours postoperatively]

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

    Secondary Outcome Measures

    1. The pain degree at rest and after movement or coughing(dynamic) [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 [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 [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 [during surgery]

      Total dosage of intraoperative sufentanil and remifentanil per weight

    5. The time to first analgesia request [within the 3 days after surgery]

      Time from operation to first rescue analgesia request

    6. The time to first mobilization [within the 3 days after surgery]

      Time from operation to ambulation

    7. Side effects [within the 5 days after surgery]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology, West China Hospital Chengdu Sichuan China 610041

    Sponsors and Collaborators

    • West China Hospital

    Investigators

    • Study Chair: Jin Liu, Department of Anesthesiology, West China Hospital, Sichuan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Min Xu, Department of Anesthesiology, West China Hospital, Sichuan University, West China Hospital
    ClinicalTrials.gov Identifier:
    NCT05034601
    Other Study ID Numbers:
    • 2021-866
    First Posted:
    Sep 5, 2021
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Funnel Chest

    Study Results

    No Results Posted as of Oct 18, 2021