Postoperative Analgesia With Erector Spinae Plane Block After Pectus Excavatum Repair in Children

NCT04081922 | Unknown DMC

• 1 other identifier: H1907-087-1049
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of erector spinae plane (ESP) block in children after pectus excavatum repair (nuss procedure).

Conditions

Pectus Excavatum

Outcome Measures

Primary Outcomes (1)

• Pain score

  The Face, Legs, Activity, Cry, Consolability (FLACC) scale is used. FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

  1 hour after surgery

Secondary Outcomes (3)

• Fentanyl dosage (mcg/kg)

  until hospital discharge (postoperative day 3)

• Dose of rescue analgesics (mg/kg)

  until hospital discharge (postoperative day 3

• Plasma concentration of ropivacaine

  5, 10, 20, 30, 60, 120 minutes after injection

Study Arms (2)

Regional analgesia using erector spinae plane block

EXPERIMENTAL

After pectus excavatum is done, intravenous patient controlled analgesia device with fentanyl is connected. Then, regional analgesia is performed for additional analgesia; ultrasound guided erector spinae plane block is performed using 0.25% ropivacaine (total 1 ml/kg) bilaterally. Plasma concentration of ropivacaine at baseline, and 5, 10, 20, 30, 60, 120 minutes after ropivacaine injection will be measured.

Procedure: Erector spinae plane block

Control

NO INTERVENTION

After pectus excavatum is done, intravenous patient controlled analgesia device with fentanyl is connected. No regional block is performed.

Interventions

Erector spinae plane block PROCEDURE

Using ultrasound, place the needle in the erector spinae fascia plane at T7-8 level. Then, 0.25% ropivacaine 0.5 ml is injected to confirm the needle location. After checking the location, 0.25% ropivacaine 0.5 ml/kg is administered. This procedure is repeated at contralateral side.

Regional analgesia using erector spinae plane block

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged between 3 and 7 years who undergo Nuss bar insertion due to Pectus excavatum

You may not qualify if:

• Allergy to opioid
• Allergy to local anesthetics
• Disease in heart, lung, kidney, and liver
• Coagulation disorder
• Disease in central and peripheral nervous system

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul national university hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jin-Tae Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin-Tae Kim, MD, PhD

CONTACT

82-2-2072-3661; jintae73@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 9, 2019
• Study Start: February 10, 2020
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

KR (1)