Erector Spinae Plane Block (ESP) Versus Thoracic Epidural Anesthesia in Video-Assisted Thoracoscopic Surgery (VATS) in Pediatric Population; a Randomized, Controlled Study (ESP)

May 6, 2021 updated by: Vittore Buzzi Children's Hospital
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary outcome:

Post-operative pain assessed by FLACC (Face, Legs, Activity: Cry, Consolability) for children age 1-5 years, and NRS (numerical rating scale) for children age 6-10 years

Secondary outcomes:

  • Opioid consumption for 48 hours post-operatively.
  • Intraoperative opiod use
  • Block failure rate (defined as Heart Rate (HR) increase of more than 20% of baseline at surgical incision)
  • Time to extubation after surgery completion After parental consent, children aged 0-10 yrs scheduled for unilateral VATS procedure will be randomized into two groups: Thoracic Epidural Group (TEA) vs Erector Spinae Plane block (ESP).

Children with history of allergy to local anesthetics, systemic coagulopathy, infection at site of puncture, severe renal or liver disease, known rib cage malformations will be excluded from the study.

Anesthesia will be induced at operator's preference; before surgery beginning children will be positioned and either TEA or ESP will be performed. In both cases, a bolus of of 0.3-0.5ml/kg of 0.2% ropivacaine will be administered, followed by an infusion of 0.2mg/kg/hr for the next 48 hours. The time from block placement to incision will be recorded, change in HR before and after incision will be documented, need for intraoperative opiod use, time to first rescue analgesic, and total amount of local anesthetic given at 24 h and 48 h post-operatively will be recorded together with pain measures as specified. Opiods will be prescribed if child presents with FLACC scores > 3 (FLACC score of 0-3 = mild pain, 4-6 = moderate, 7-10 = severe), or VAS >5.

Total opioid consumption will be recorded.

Statistical analysis

Intention to treat analysis will be performed. Quantitative variables will be described as mean and standard deviation (sd) or median and interquartile range (IQR) if not normally distributed (Shapiro-Wilks test) For primary outcome, VAS or FLACC score will be compared with t-test or Mann-Whitney test Opioid consumption will be compared with t-test or Mann-Whitney test Block failure rate will be compared with chi2 test Time to extubation will be compared with log rank test

Sample size With 37 patients for group a power of 80% will be achieved to identify as significant a difference in mean pain score when sd is 1,5 times greater than mean. Alpha error will be 0.05 and a two-sample t-test will be applied.

Randomization A random block centralized randomization list will be generated before study start with Ralloc command in Stata. It will be stratified by center. To avoid allocation concealment the closed envelope method will be used.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Erector Spinae plane Block
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
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.
ACTIVE_COMPARATOR: Thoracic Epidural Anesthesia
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: First 48 hours after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative opiod use
Time Frame: Surgery duration
Total amount of intraoperative opiods
Surgery duration
Postoperative opiod consumption
Time Frame: First 48 hours after surgery
Determine if ESP will decrease postoperative opioid consumption compared to Thoracic Epidural Anesthesia
First 48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vittore Buzzi Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (ACTUAL)

May 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESP1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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