ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure

Not Applicable

Completed

• Conditions: Analgesia; Pectus Excavatum; Nerve Block
• Interventions: Procedure: ESPB group; Procedure: TPVB group

• Registration Number: NCT05034601
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-21
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-05
• Study Start: 2021-09-25
• Primary Completion: 2023-03-23
• Study Completion: 2023-03-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESPB group	ESPB group	0.25% ropivacaine 0.5 ml/kg is injected at the fascial plane deep to the erector spinae muscle
TPVB group	TPVB group	0.25% ropivacaine 0.5 ml/kg is injected into the thoracic paravertebral space (T5) using TPVB approach.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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
Total dosage of intraoperative sufentanil and remifentanil	during surgery	Total dosage of intraoperative sufentanil and remifentanil per weight
The time to first analgesia request	within the 3 days after surgery	Time from operation to first rescue analgesia request
The time to first mobilization	within the 3 days after surgery	Time from operation to ambulation
Side effects	within the 5 days after surgery	Side effects such as pneumothorax, local anesthetic toxicity, postoperative nausea and vomiting

Trial Locations

Locations (1)

Department of Anesthesiology, West China Hospital; 🇨🇳 Chengdu, Sichuan, China