ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05034601
• Other study ID #: 2021-866
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Analgesia
• Funnel Chest
• Nerve Block
• Pectus Excavatum

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