NCT04878341

Brief Summary

Aim of the study is to investigate the efficacy and safety of continuous ESP block in children under the age of 10 yrs undergoing video-assisted thoracoscopic procedures, compared to Thoracic Epidural Anesthesia (TEA).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

1.4 years

First QC Date

May 4, 2021

Last Update Submit

May 6, 2021

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain

    Postoperative pain will be assessed by FLACC (Face, Legs, Activity: Cry, Consolability) scale for children aged 1-5 years, and NRS (numerical rating scale) for children aged 6-10 years

    First 48 hours after surgery

Secondary Outcomes (2)

  • Intraoperative opiod use

    Surgery duration

  • Postoperative opiod consumption

    First 48 hours after surgery

Study Arms (2)

Erector Spinae plane Block

EXPERIMENTAL

After induction of general anesthesia, patients will be positioned in lateral decubitus with surgical site up and the transverse process of T5-T7 vertebrae and Erector Spinae (ES) fascia will be located with a linear ultrasound probe. A 19G or 20G epidural needle (according to age) will be positioned under the ES muscle and a bolus of of 0.3-0.5ml/kg of 0.2% ropivacaine will be administered; after hydrodissection, the catheter will be threaded, followed by an infusion of 0.2mg/kg/hr for the next 48 hours.

Other: Erector Spinae Plane Block

Thoracic Epidural Anesthesia

ACTIVE COMPARATOR

After induction of general anesthesia, patients will be positioned in lateral decubitus with surgical site up and a 19G or 20G epidural needle (according to age) will be positioned at T5-T7 level with cathether placement; a bolus of of 0.3-0.5ml/kg of 0.2% ropivacaine will be administered and followed by an infusion of 0.2mg/kg/hr for the next 48 hours.

Other: Erector Spinae Plane Block

Interventions

Erector Spinae Plane BlockOTHER

The ESP is fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Its proposed mechanism of action is via blockade of the dorsal and ventral rami of the thoracic spinal nerves and sympathetic fibers.

Erector Spinae plane BlockThoracic Epidural Anesthesia

Eligibility Criteria

Age1 Month - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA I-III
  • Scheduled for Video-Assisted Thoracoscopic Procedure
  • Parental consent

You may not qualify if:

  • Parental refusal
  • History of allergy to local anesthetics
  • Systemic coagulopathy
  • Local infection at puncture site
  • Severe renal or liver disease
  • Known rib cage malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Vittore Buzzi

Milan, 20154, Italy

Location

Related Publications (5)

  • Swenson Schalkwyk A, Flaherty J, Hess D, Horvath B. Erector spinae catheter for post-thoracotomy pain control in a premature neonate. BMJ Case Rep. 2020 Sep 7;13(9):e234480. doi: 10.1136/bcr-2020-234480.

    PMID: 32900720BACKGROUND

  • Gaio-Lima C, Costa CC, Moreira JB, Lemos TS, Trindade HL. Continuous erector spinae plane block for analgesia in pediatric thoracic surgery: A case report. Rev Esp Anestesiol Reanim (Engl Ed). 2018 May;65(5):287-290. doi: 10.1016/j.redar.2017.11.010. Epub 2018 Jan 19. English, Spanish.

    PMID: 29370900BACKGROUND

  • De la Cuadra-Fontaine JC, Concha M, Vuletin F, Arancibia H. Continuous Erector Spinae Plane block for thoracic surgery in a pediatric patient. Paediatr Anaesth. 2018 Jan;28(1):74-75. doi: 10.1111/pan.13277. No abstract available.

    PMID: 29226529BACKGROUND

  • Patel NV, Glover C, Adler AC. Erector Spinae Plane Catheter for Postoperative Analgesia After Thoracotomy in a Pediatric Patient: A Case Report. A A Pract. 2019 May 1;12(9):299-301. doi: 10.1213/XAA.0000000000000914.

    PMID: 30844822BACKGROUND

  • Holland EL, Bosenberg AT. Early experience with erector spinae plane blocks in children. Paediatr Anaesth. 2020 Feb;30(2):96-107. doi: 10.1111/pan.13804. Epub 2020 Jan 27.

    PMID: 31883421BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Anna Camporesi, MD

CONTACT

+393355793744anna.camporesi@asst-fbf-sacco.it

Veronica Diotto, MD

CONTACT

+390563635157veronica.diotto@asst-fbf-sacco.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 7, 2021

Study Start

July 1, 2021

Primary Completion

December 1, 2022

Study Completion

April 1, 2023

Last Updated

May 7, 2021

Record last verified: 2021-05

Locations

IT(1)