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Pain, PostoperativeESPNCT04878341

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

A study testing Erector Spinae Plane Block in people with Pain, Postoperative, run by Vittore Buzzi Children's Hospital at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 1 month to 10 years
Conditions the study is for
Pain, Postoperative
What is being tested?
Erector Spinae Plane Block
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteItaly
Study dates
Jul 2021to Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Anna Camporesi, MD contact

+393355793744

anna.camporesi@asst-fbf-sacco.it

Veronica Diotto, MD contact

+390563635157

veronica.diotto@asst-fbf-sacco.it

Italy1 site

  • Children's Hospital Vittore Buzzi

    Milan, 20154

    Anna Camporesi, MD, +393355793744, anna.camporesi@asst-fbf-sacco.it

    Veronica Diotto, MD, +390263635157, veronica.diotto@asst-fbf-sacco.it

Other trials in Italy

About this study

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).

Read the 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.

Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04878341
Study groupRoleWhat they receive
Erector Spinae plane BlockExperimentalAfter 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.
Receives: Other: Erector Spinae Plane Block
Thoracic Epidural AnesthesiaActive comparatorAfter 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.
Receives: Other: Erector Spinae Plane Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: First 48 hours after surgery

Secondary outcomes (2)

  1. Intraoperative opiod use

    Total amount of intraoperative opiods

    Measured: Surgery duration

  2. Postoperative opiod consumption

    Determine if ESP will decrease postoperative opioid consumption compared to Thoracic Epidural Anesthesia

    Measured: First 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2021
  2. Study startJul 2021 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionApr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04878341
Sponsor's protocol ID
ESP1
Acronym
ESP
Status last verified
May 2021
First submitted
4 May 2021
Last updated
7 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32900720

  • 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.

    PubMed 29370900

  • 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.

    PubMed 29226529

  • 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.

    PubMed 30844822

  • 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.

    PubMed 31883421

Questions about this trial

What is this clinical trial studying?

A study testing Erector Spinae Plane Block in people with Pain, Postoperative, run by Vittore Buzzi Children's Hospital at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anna Camporesi, MD (+393355793744, anna.camporesi@asst-fbf-sacco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative pain (time frame: First 48 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04878341, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.

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