ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Nerve Block; Pectus Excavatum
• Intervention / Treatment: Procedure: ESPB group; Procedure: TPVB group

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Yang, MD; Phone Number: +86- 18980602269; Email: yangjing@wchscu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Department of Anesthesiology, West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2021
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): March 23, 2023

Study Registration Dates

• First Submitted: August 21, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Funnel Chest
• Other Study ID Numbers: 2021-866

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No