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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05034601
Other study ID # 2021-866
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 25, 2021
Est. completion date March 23, 2023

Study information

Verified date November 2023
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date March 23, 2023
Est. primary completion date March 23, 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
China Department of Anesthesiology, West China Hospital Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary Total dosage of intraoperative sufentanil and remifentanil Total dosage of intraoperative sufentanil and remifentanil per weight during surgery
Secondary The time to first analgesia request Time from operation to first rescue analgesia request within the 3 days after surgery
Secondary The time to first mobilization Time from operation to ambulation within the 3 days after surgery
Secondary Side effects Side effects such as pneumothorax, local anesthetic toxicity, postoperative nausea and vomiting within the 5 days after surgery
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