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Anesthesia, LocalNCT04452656

Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block in Pediatric.

A study testing bilateral erector spinae block in people with Anesthesia, Local and Analgesia, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized, double-blinded, study aims to compare the efficacy of analgesia and any side effects of U/S guided bilateral Erector SpinaePlane block versus non-block t paediatric patients undergoing corrective cardiac surgeries. Read more about this study

Who is it for?
Ages 6 months to 7 years
Conditions the study is for
Anesthesia, Local, Analgesia
What is being tested?
bilateral erector spinae block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteEgypt
Study dates
20 Jul 2020to 15 Aug 2021
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 6 months to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age:6 months-7 years.
  • ASA, American Society of Anesthesiology, II and III .
  • Patients undergoing cardiac surgeries with midline sternotomy incision.

Who cannot join

  • Patients whose parents or legal guardians refusing to participate.
  • Preoperative mechanical ventilation.
  • Preoperative inotropic drug infusion.
  • Known or suspected coagulopathy.
  • Any congenital anomalies of the sacrum/the vertebral column or any infection at the site of injection.
  • Known or suspected allergy to any of the studied drugs.
  • Elevated liver enzymes more than the normal values.
  • Renal function impairment (Creatinine value more than 1.2 mg/dl or BUN more than 20mg/dl).

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Cairo University Hospitals

    Cairo

Other trials in Egypt

About this study

Official title: Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Cardiac Surgeries. a Randomized Controlled Study.

This randomized, double-blinded, study aims to compare the efficacy of analgesia and any side effects of U/S guided bilateral Erector SpinaePlane block versus non-block t paediatric patients undergoing corrective cardiac surgeries.

Read the detailed description

Our study will be designed to estimate and compare the analgesic effect of single shotbilatral erector spinae plane block in pediatric patients undergoing corrective cardiac surgeries versus non-block as the control group. Our primary outcome will be the total dose of intraoperative fentanyl boluses.

Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A medical personnel not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anesthesiologist who is expert in doing the ESP block in patients included within the block group. The anesthesia team who managed the patients intraoperatively did not share in recording data for the research. However, another physcian will be responsible for recording the intraoperative data.

Being tested
bilateral erector spinae block
Keywords
Erector spinae plane block, Pediatric, sternotomy
Medical subject headings
Agnosia

What participants receive

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

  • bilateral erector spinae blockProcedure or surgery

    An ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process.

    Three muscles; trapezius , rhomboids major , and erector spinae will be identified superior to the hyperechoic transverse process.

    Using in-plane approach a 25 G needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle.

    Correct needle tip location will be confirmed by injecting 3 mL of saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process..

    0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) will be injected and visualizing the linear LA spread in the fascial plane between the erector spinae muscle andthe transverse process12.

Study groups in NCT04452656
Study groupRoleWhat they receive
bilateral erector spinae plane blockActive comparatorThe patient WILL receive bilateral erector spinae plane block.
Receives: Procedure: bilateral erector spinae block
NO BLOCKNo interventionThe patient will not receive Erector spinae plane block

What is being measured

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

  1. The total dose of intraoperative fentanyl boluses in microgram.

    The total dose of intraoperative fentanyl boluses in microgram

    Measured: 3 months

Secondary outcomes (3)

  1. Pain assessment at postoperatively by FLACC score

    Pain assessment postoperatively by FLACC score

    Measured: 3 months

  2. Total consumption of morphine during the first 24 hours postoperatively.

    Total consumption of morphine during the first 24 hours postoperatively

    Measured: 3 monts

  3. extubation time

    time from finishing skin incision suturing and cessation of anesthesia to successful removal of endotracheal tube.

    Measured: 3 months

Timeline

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

  1. First posted30 Jun 2020
  2. Study start20 Jul 2020
  3. Primary completion5 Aug 2021
  4. Study completion15 Aug 2021

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04452656
Sponsor's protocol ID
N159-2020
Status last verified
Dec 2021
First submitted
25 Jun 2020
Last updated
21 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The patients data are confidential

Publications

  • Anand VG, Kannan M, Thavamani A, Bridgit MJ. Effects of dexmedetomidine added to caudal ropivacaine in paediatric lower abdominal surgeries. Indian J Anaesth. 2011 Jul;55(4):340-6. doi: 10.4103/0019-5049.84835.

    PubMed 22013248

  • Anand KJ, Hickey PR. Halothane-morphine compared with high-dose sufentanil for anesthesia and postoperative analgesia in neonatal cardiac surgery. N Engl J Med. 1992 Jan 2;326(1):1-9. doi: 10.1056/NEJM199201023260101.

    PubMed 1530752

  • El Shamaa HA, Ibrahim M. A comparative study of the effect of caudal dexmedetomidine versus morphine added to bupivacaine in pediatric infra-umbilical surgery. Saudi J Anaesth. 2014 Apr;8(2):155-60. doi: 10.4103/1658-354X.130677.

    PubMed 24843324

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

    PubMed 27501016

  • Kaushal B, Chauhan S, Magoon R, Krishna NS, Saini K, Bhoi D, Bisoi AK. Efficacy of Bilateral Erector Spinae Plane Block in Management of Acute Postoperative Surgical Pain After Pediatric Cardiac Surgeries Through a Midline Sternotomy. J Cardiothorac Vasc Anesth. 2020 Apr;34(4):981-986. doi: 10.1053/j.jvca.2019.08.009. Epub 2019 Aug 12.

    PubMed 31515190

  • Munoz F, Cubillos J, Bonilla AJ, Chin KJ. Erector spinae plane block for postoperative analgesia in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882. doi: 10.1007/s12630-017-0894-0. Epub 2017 Apr 26. No abstract available.

    PubMed 28447318

  • 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

  • Hernandez MA, Palazzi L, Lapalma J, Forero M, Chin KJ. Erector Spinae Plane Block for Surgery of the Posterior Thoracic Wall in a Pediatric Patient. Reg Anesth Pain Med. 2018 Feb;43(2):217-219. doi: 10.1097/AAP.0000000000000716.

    PubMed 29278605

  • Ueshima H, Otake H. RETRACTED: Clinical experiences of erector spinae plane block for children. J Clin Anesth. 2018 Feb;44:41. doi: 10.1016/j.jclinane.2017.10.021. No abstract available.

    PubMed 29100022

  • Kaplan I, Jiao Y, AuBuchon JD, Moore RP. Continuous Erector Spinae Plane Catheter for Analgesia After Infant Thoracotomy: A Case Report. A A Pract. 2018 Nov 1;11(9):250-252. doi: 10.1213/XAA.0000000000000799.

    PubMed 29794802

  • Hernandez MA, Palazzi L, Lapalma J, Cravero J. Erector spinae plane block for inguinal hernia repair in preterm infants. Paediatr Anaesth. 2018 Mar;28(3):298-299. doi: 10.1111/pan.13325. Epub 2018 Jan 17.

    PubMed 29341379

  • Merkel S, Voepel-Lewis T, Malviya S. Pain assessment in infants and young children: the FLACC scale. Am J Nurs. 2002 Oct;102(10):55-8. doi: 10.1097/00000446-200210000-00024. No abstract available.

    PubMed 12394307

Questions about this trial

What is this clinical trial studying?

A study testing bilateral erector spinae block in people with Anesthesia, Local and Analgesia, run by Cairo University at 1 site in Egypt.

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 8 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: finished, as of the sponsor's last update on 21 Dec 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 Egypt. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The total dose of intraoperative fentanyl boluses in microgram. (time frame: 3 months). 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 NCT04452656, which also lists 12 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 21 Dec 2021.

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