ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure

NCT05034601 | Completed

• 1 other identifier: 2021-866
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Block; Analgesia; Pectus Excavatum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The pain degree at rest and after movement or coughing(dynamic)

  at 3, 6, 12, 24, and 48 hours after surgery

• total rescue morphine-equivalent consumption per weight

  at 24 and 48 hours after surgery

• Emergence agitation at 5, 15, 30 min after extubation

  at 5, 15, 30 min after extubation

• Total dosage of intraoperative sufentanil and remifentanil

  during surgery

• The time to first analgesia request

  within the 3 days after surgery

Study Arms (2)

ESPB group

EXPERIMENTAL

0.25% ropivacaine 0.5 ml/kg is injected at the fascial plane deep to the erector spinae muscle

Procedure: ESPB group

TPVB group

ACTIVE COMPARATOR

0.25% ropivacaine 0.5 ml/kg is injected into the thoracic paravertebral space (T5) using TPVB approach.

Procedure: TPVB group

Interventions

ESPB group PROCEDURE

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.

Also known as: Erector spinae plane block

ESPB group

TPVB group PROCEDURE

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.

Also known as: Thoracic paravertebral block

TPVB group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 4 to 18 years Scheduled for elective Nuss surgery Written informed consent is obtained from parents of each patient.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Department of Anesthesiology, West China Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• 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.

  PMID: 35164831 DERIVED

MeSH Terms

Conditions

Agnosia; Funnel Chest

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jin Liu

  Department of Anesthesiology, West China Hospital, Sichuan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology, West China Hospital, Sichuan University

Study Record Dates

• First Submitted: August 21, 2021
• First Posted: September 5, 2021
• Study Start: September 25, 2021
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)