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ESP Block in Pediatric Patients for Postoperative Analgesia (ESP1)

Primary Purpose

Opioid Use, Pain, Postoperative, Quality of Life

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacain
saline
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Feri̇de Karacaer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Regional analgesia group

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain assesment in infant/toddlers
Pain assessment will be based on Modified objective pain scale

Full Information

First Posted
August 4, 2018
Last Updated
January 17, 2022
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT03627897
Brief Title
ESP Block in Pediatric Patients for Postoperative Analgesia
Acronym
ESP1
Official Title
Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Patients Undergoing Cardiac Surgery: A Double-Blind, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Pain, Postoperative, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The children will randomly assigned into two study groups by a computer-generated random number list. The children in group B will be administered bilateral ESPB with 0.25% bupivacaine by non-blinded researcher to the study groups), while the children in group C will be not administered any intervention.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regional analgesia group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Intervention Description
The erector spinae plane blocks proceed with 0,5 ml/kg of 0,25% bupivacain (Group B).
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
No drugs or interventions were administered to the control group.
Primary Outcome Measure Information:
Title
Morphine consumption
Description
Total consumption of rescue analgesia by morphine (mcg/kg)
Time Frame
24 hours after arrival in Intensive care unit
Secondary Outcome Measure Information:
Title
Pain assesment in infant/toddlers
Description
Pain assessment will be based on Modified objective pain scale
Time Frame
24 hours after arrival in intensive care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 2-10 years old patients Pediatric patients undergoing cardiac surgery with median sternotomy Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FERİDE KARACAER, Specialist
Organizational Affiliation
Çukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Feri̇de Karacaer
City
Adana
State/Province
In The USA Or Canada, Please Select...
ZIP/Postal Code
01330
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29226529
Citation
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.
Results Reference
result
PubMed Identifier
17678782
Citation
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.
Results Reference
result

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ESP Block in Pediatric Patients for Postoperative Analgesia

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