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Opioid UsePhase 4ESP1NCT03627897

ESP Block in Pediatric Patients for Postoperative Analgesia

A Phase 4 study testing Bupivacain and saline in people with Opioid Use and Pain, Postoperative, run by Cukurova University at 1 site in Turkey (Türkiye).

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

Pediatric cardiac surgery is associated with moderate to severe postoperative pain that is related to median sternotomy. In a fast-track protocol, used in modern-day cardiac surgical care, early extubation may be facilitated by effective postoperative pain control, which also helps in maintaining hemodynamic stability… Read more about this study

Who is it for?
Ages 2 to 10 years
Conditions the study is for
Opioid Use, Pain, Postoperative, Quality of Life
What is being tested?
Bupivacain and saline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2019to 1 Apr 2021
Phase
Phase 4
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 2 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 2-10 years old patients
  • Pediatric patients undergoing cardiac surgery with median sternotomy

Who cannot join

  • A history of develop mental delay or mental retardation
  • Any other heart defect
  • Known allergy to any local anesthetic
  • Clinically significant liver or renal disease.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Feri̇de Karacaer

    Adana, In the USA Or Canada, Please Select..., 01330

Other trials in Turkey (Türkiye)

About this study

Official title: Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Patients Undergoing Cardiac Surgery: A Double-Blind, Randomized, Controlled Study

Pediatric cardiac surgery is associated with moderate to severe postoperative pain that is related to median sternotomy. In a fast-track protocol, used in modern-day cardiac surgical care, early extubation may be facilitated by effective postoperative pain control, which also helps in maintaining hemodynamic stability This prospective, randomized, and double-blind study is designed to examine the efficacy and safety of the ESP block on the postoperative analgesia in pediatric patients after cardiac surgery.

40 pediatric patients aged 2-10 years, undergoing cardiac surgery with median sternotomy will be enrolled. Children received oral premedication of midazolam 0.5 mg/kg. After i.v. access will be obtained, fentanyl 5 µg/kg will be given. Anesthesia will be induced with 2-3 mg/kg propofol and all children will receive rocuronium 0,6 mg/kg for tracheal intubation.Subsequently, fentanyl 5 µg/kg will be administered prior to incision and an additional 5 microg/kg of fentanyl given prior to CPB. Anesthesia will be maintained with %2-3 sevoflurane. Fentanyl 1 µg/kg will be given before skin closure at the end of surgery. Patients were randomly assigned to a study group by the computer generated number table. Children in group B were administered bilateral ESPB with 0.25% bupivacaine, while children in group C did not receive any intervention. Following inhalational induction and endotracheal tube placement, the patient will be turned into a left lateral decubitus position and bilateral ESP block will be performed under aseptic conditions.

Read more

ESP block at bilateral side will be performed in the lateral decubitis position and at T5 transverse process level by using 10-MHz liner ultrasound probe. The probe will be located 1 cm lateral to T5 spinous process in longitudinal parasagittal orientation. Simplex A 50mm (B.Braun, Germany) will be inserted by using out of plane technique. The ESP blocks proceed with 0,5 ml/kg of 0,25% bupivacaine (Group B).

Postoperative care: All the patients then will be shifted to the intensive care unit (ICU) after the surgery and managed with the institution's ICU protocol for postoperative pain management and ventilation.The postoperative analgesia will be provided with rescue intravenous (IV) morphine 0.05 mg/kg. Both the groups will receive IV paracetamol 15 mg/kg every 6 hours as a component of multimodal analgesia.

Postoperative sternal wound pain will be judged by the Modified Objectice Pain Scale.

Postoperative sedation levels will be evaluated with Ramsya sedation score.

Read the detailed description

Reducing the pain from surgical procedures performed early in life psychologically reduces the pain experienced by children in subsequent procedures. Pediatric cardiac surgery is associated with moderate to severe postoperative pain that is related to median sternotomy. Pediatric cardiac surgical patients usually undergo multiple surgical interventions and hospital admissions and will benefit from effective pain relief during their initial surgery. In a fast-track protocol, used in modern-day cardiac surgical care, early extubation may be facilitated by executive postoperative pain control, which also helps in maintaining hemodynamic stability.

Neuraxial analgesia techniques are effective for sternotomy pain. However cardiac surgery procedures potentially require cardiopulmonary bypass (CPB) and systemic anticoagulation, thus increasing the epidural hematoma risk. Erector spinae plane (ESP) block appears to provide adequate regional analgesia for multiple dermatomal levels covering the sternum without increasing the risks associated with neuraxial blocks.

This prospective, randomized, and double-blind study is designed to examine the efficacy and safety of the ESP block on the postoperative analgesia in pediatric patients after cardiac surgery. We hypothesized that the ESP block significantly improves pain control, as evidenced by the reduced need for systemic postoperative analgesics.

METHOD After obtaining approval from the Institutional Review Boards at Çukurova University Medical Faculty, 40 pediatric patients aged 2-10 years, undergoing cardiac surgery with median sternotomy will be enrolled. Parental consent and patient assent from patients of an appropriate age will be obtained. Children with a preoperative ejection fraction<35%, a ventricular arrhythmia/dysrhythmia, a low cardiac output syndrome, a redo or an emergency surgery, a scoliosis or other anatomic contraindication to ESPB, a history of bleeding diathesis, an anticoagulant drug use at the time of the block and with known allergies to any of the study drugs will be excluded from the study.

Anesthesia Children received oral premedication of midazolam 0.5 mg/kg. After i.v. access will be obtained, fentanyl 5 µg/kg will be given. Anesthesia will be induced with 2-3 mg/kg propofol and all children will receive rocuronium 0,6 mg/kg for tracheal intubation. After tracheal intubation, an arterial line, central venous catheter, and urinary catheter will be inserted. Subsequently, fentanyl 5 µg/kg will be administered prior to incision and an additional 5 microg/kg of fentanyl given prior to CPB. Anesthesia will be maintained with %2-3 sevoflurane. Fentanyl 1 µg/kg will be given before skin closure at the end of surgery.

Intervention Patients were randomly assigned to a study group by the computer generated number table. Children in group B will be administered bilateral ESPB with 0.25% bupivacaine, while children in group C did not receive any intervention. The anesthesia resident observing the patient in the postperative period and the intensive care unit staff giving postoperative care will be blind to the study protocol.

Following anesthesia induction and endotracheal tube placement, the patient will be turned into a left lateral decubitus position and bilateral ESP block will be performed under aseptic conditions.

ESP block at bilateral side will be performed in the lateral decubitis position and at T5 transverse process level by using 10-MHz liner ultrasound probe. The probe will be located 1 cm lateral to T5 spinous process in longitudinal parasagittal orientation. Simplex A 50mm (B.Braun, Germany) will be inserted by using out of plane technique. The ESP blocks proceed with 0,5 ml/kg of 0,25% bupivacaine (Group B). The injection will be applied after the confirmation of location by hydrodissection developed anterior to erector spinae muscle with 1-2 ml of local anesthetic solution.

Postoperative care All the patients then will be shifted to the intensive care unit (ICU) after the surgery and managed with the institution's ICU protocol for postoperative pain management and ventilation.The postoperative analgesia will be provided with rescue intravenous (IV) morphine 0.05 mg/kg. Both the groups will receive IV paracetamol 15 mg/kg every 6 hours as a component of multimodal analgesia.

Postoperative sternal wound pain will be judged by the Modified Objectice Pain Scale.

Postoperative sedation levels will be evaluated with Ramsay sedation score.

Being tested
Bupivacain, saline
Medical subject headings
Pain, Postoperative

What participants receive

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

  • BupivacainDrug

    The erector spinae plane blocks proceed with 0,5 ml/kg of 0,25% bupivacain (Group B).

  • salineDrug

    No drugs or interventions were administered to the control group.

Study groups in NCT03627897
Study groupRoleWhat they receive
Regional analgesia groupExperimentalESP block at bilateral side will be performed in the lateral decubitis position and at T5 transverse process level by using 10-MHz liner ultrasound probe. The probe will be located 1 cm lateral to T5 spinous process in longitudinal parasagittal orientation. Simplex A 50mm (B.Braun, Germany) will be inserted by using out of plane technique. The ESP blocks proceed with 0,5 ml/kg of 0,25% bupivacaine
Receives: Drug: Bupivacain
Control groupOtherNot described
Receives: Drug: saline

What is being measured

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

  1. Morphine consumption

    Total consumption of rescue analgesia by morphine (mcg/kg)

    Measured: 24 hours after arrival in Intensive care unit

Secondary outcomes (1)
  1. Pain assesment in infant/toddlers

    Pain assessment will be based on Modified objective pain scale

    Measured: 24 hours after arrival in intensive care unit

Timeline

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

  1. First posted14 Aug 2018
  2. Study start1 Aug 2019
  3. Primary completion1 Mar 2021
  4. Study completion1 Apr 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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03627897
Sponsor's protocol ID
ESPediatrics
Acronym
ESP1
Status last verified
Jan 2022
First submitted
4 Aug 2018
Last updated
1 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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
  • Barr AM, Tutungi E, Almeida AA. Parasternal intercostal block with ropivacaine for pain management after cardiac surgery: a double-blind, randomized, controlled trial. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):547-53. doi: 10.1053/j.jvca.2006.09.003. Epub 2006 Dec 22.

    PubMed 17678782

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacain and saline in people with Opioid Use and Pain, Postoperative, run by Cukurova University at 1 site in Turkey (Türkiye).

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 2 inclusion and 4 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 1 Feb 2022. 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 Turkey (Türkiye). 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Morphine consumption (time frame: 24 hours after arrival in Intensive care unit). 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 NCT03627897, which also lists 2 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 1 Feb 2022.

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