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Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Aortic Coarcitectomy

Primary Purpose

Aortic Coarctation, Erector Spinae Plane Block, Paediatric

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Fentanyl
Erector spinae plane block
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Coarctation

Eligibility Criteria

3 Months - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: 3 months-12 months.
  2. A III .
  3. Patients undergoing aortic coarcitectomy operation undergone with Lateral thoracotomy incision.

Exclusion Criteria:

  1. Patients whose parents or legal guardians refusing to participate.
  2. Preoperative mechanical ventilation.
  3. Preoperative inotropic drug infusion.
  4. Patients undergoing aortic coarctectomy operation undergone with midline sternotomy incision.
  5. Known or suspected coagulopathy.
  6. Any congenital anomalies of the sacrum/the vertebral column or any infection at the site of injection.
  7. Known or suspected allergy to any of the studied drugs.
  8. Elevated liver enzymesmore than the normal values.
  9. Renal function impairment (Creatinine value more than 1.2mg/dl or blood urea nitrogen more than 20mg/dl).

Sites / Locations

  • Kasr Al-Ainy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control group

ESPB group

Arm Description

This group will receive fentanyl infusion only

This group will receive fentanyl infusion plus Ultrasound guided ESPB

Outcomes

Primary Outcome Measures

The total dose of intraoperative fentanyl boluses.
microgram/kg

Secondary Outcome Measures

Face, Leg, Activity, Cry, Consolability
Face 0: if patient has a relaxed face 1: if patient has a worried look ,eyes partially closed, mouth pursed 2: if patient has deep furrows in the forehead, with closed eyes, open mouth. Legs 0: if patient has usual tone and motion to limbs. 1: if patient has increase tone, rigidity. 2: if patient has hyper tonicity, legs pulled tight, exaggerated flexion/extension of limbs. Activity 0: if patient moves easily and freely. 1: if patient shifts positions, guarding. 2:if patient is in fixed position, side-to-side head movement. Cry 0: if patient has no cry/moan awake or asleep 1: if patient has occasional moans, cries. 2: if patient has frequent/continuous moans, cries, grunts. Consolability 0: if patient is calm and does not require consoling 1: if patient responds to comfort by touch or talk in ½- 1 minute 2: if patient requires constant comforting or unable to console.
postoperative Morphine
mg/kg

Full Information

First Posted
October 15, 2019
Last Updated
July 7, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04128540
Brief Title
Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Aortic Coarcitectomy
Official Title
Analgesic Efficacy of Ultrasound Guided Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Aortic Coarcitectomy. a Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
Pain is considered to be subjective, however in children it is believed to be felt rather than expressed, because they often depend on the caregiver for their safety and well-being. There is significant pain after thoracotomy surgery because of pleural and muscular damage, ribcage disruption, and intercostal nerve damage during surgery, which if not effectively managed, it will lead to various systemic complications; pulmonary (atelectasis, pneumonia, and stasis of bronchial secretions), cardiovascular (increased oxygen consumption and tachycardia), musculoskeletal (muscle weakness), increased neuro-hormonal response and prolonged hospital stay. So adequate and sufficient post-operative analgesia for paediatric patients is mandatory. The use of highly potent opioids for paediatric cardiac anaesthesia has gained widespread popularity during the last 20 years.In addition to the important advantage of hemodynamic stability, the large-dose opioid-based anaesthetic techniques also blunt the stress response, However, large doses can cause oversedation, respiratory depression, and prolonged mechanical ventilation after surgery. Erector Spinae Plane Block (ESPB), recently developed by Forero et al, is a novel technique in management of thoracic neuropathic pain guided by ultrasound. It became popular because it is much safer and easily administered than other alternative regional techniques as thoracic paravertebral and thoracic epidural block. To our knowledge, Erector Spinae Plane Block (ESPB) performed in aortic coarcitectomy operations has not been investigated yet.This has encouraged the performance of the present study.
Detailed Description
Our study will be designed to estimate and compare the analgesic effect of single shot erector spinae plane block in pediatric patients undergoing aortic coarcitectomy via thoracotomy incision versus fentanyl infusion as the control group. Our primary outcome will be the total dose of intraoperative fentanyl bouluses. 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 ESPB in patients included within the block group. this expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data. The study will be conducted in the pediatric cardiothoracic operation theatre in Abu El Reesh Pediatric Hospital -Cairo University on 28 pediatric patients aged 3 months-12 months, ASA III undergoing aortic coarcitectomy (with thoracotomy incision). All patients will attend at the pre- anesthesia room with their parents 1 hour before the procedure after taking approval of research ethical comittee and informed consent. Detailed history from the parents will be taken followed by a full and detailed clinical examination of the child then all investigations including CBC, coagulation profile, liver enzymes, kidney function tests, Chest x-ray ,echocardiography and blood grouping will be checked. ECG, pulse oximetry and non-invasive blood pressure will be applied to all patients. All patients will be premedicated by intramuscular midazolam 2mg/Kg and atropine 0.2 mg/Kg 20 minutes before induction of anesthesia. Anesthesia will be induced in all patients by sevoflurane 5% in 100% O2 followed by Placement of peripheral I.V cannula and IV administration of fentanyl (1-2µg/kg). Oral endotracheal intubation will be facilitated by IV atracurium 0.5 mg/kg and then capnogram will be connected to monitor End-tidal CO2 and muscle relaxation will be maintained by atracurium infusion in a dose of 0.5 mg/ kg/ hr. All patients will be mechanically ventilated using pressure controlled mode with FiO2 50%, positive end expiratory pressure (PEEP) 5 cmH2O,I: E ratio of 1:2,peak inspiratory pressure (PIP) will be set to deliver a tidal volume of 6-8 ml/kg and respiratory rate will be 15 to 35 cycle / minute according to the age. our aim is to keep end tidal CO2 between 30-40 mmHg. Sevoflurane will be used for maintenance of anaesthesia and its MAC will be determined by using bispectoral index (targeting 40-60) to standardize the depth of anaesthesia. After insertion of a central venous catheter and an arterial cannula , nasopharyngeal temperature probe will be placed and the patient's position will be changed from supine to right lateral position.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Coarctation, Erector Spinae Plane Block, Paediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
This group will receive fentanyl infusion only
Arm Title
ESPB group
Arm Type
Active Comparator
Arm Description
This group will receive fentanyl infusion plus Ultrasound guided ESPB
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
fentanyl infusion at a dose of (1 μg/kg/hour) after induction of anesthesia and to be continued all through the whole operation.rescue analgesia by a bolus of (Fentanyl 1mcg/kg) will be given to the patients in either group, if either systolic blood pressure or heart rate increased more than 20% of the baseline readings.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
ultrasound guided erector spinae plane block by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%). This will be performed at the same side of the planned thoracotomy under strict aseptic precautions.A high frequency 12 MHz linear 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-cephalic direction, until the tip is deep to erector spinae muscle. Correct needle tip location will be confirmed by injecting 3 mL of normal saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process..
Primary Outcome Measure Information:
Title
The total dose of intraoperative fentanyl boluses.
Description
microgram/kg
Time Frame
From skin incision till 5 minutes after skin closure
Secondary Outcome Measure Information:
Title
Face, Leg, Activity, Cry, Consolability
Description
Face 0: if patient has a relaxed face 1: if patient has a worried look ,eyes partially closed, mouth pursed 2: if patient has deep furrows in the forehead, with closed eyes, open mouth. Legs 0: if patient has usual tone and motion to limbs. 1: if patient has increase tone, rigidity. 2: if patient has hyper tonicity, legs pulled tight, exaggerated flexion/extension of limbs. Activity 0: if patient moves easily and freely. 1: if patient shifts positions, guarding. 2:if patient is in fixed position, side-to-side head movement. Cry 0: if patient has no cry/moan awake or asleep 1: if patient has occasional moans, cries. 2: if patient has frequent/continuous moans, cries, grunts. Consolability 0: if patient is calm and does not require consoling 1: if patient responds to comfort by touch or talk in ½- 1 minute 2: if patient requires constant comforting or unable to console.
Time Frame
30 min, 60 min, 2 hours, 4hours, 8hours, 16hours and 24 hours postoperatively
Title
postoperative Morphine
Description
mg/kg
Time Frame
30 minutes postoperative till 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 3 months-12 months. A III . Patients undergoing aortic coarcitectomy operation undergone with Lateral thoracotomy incision. Exclusion Criteria: Patients whose parents or legal guardians refusing to participate. Preoperative mechanical ventilation. Preoperative inotropic drug infusion. Patients undergoing aortic coarctectomy operation undergone with midline sternotomy incision. 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 enzymesmore than the normal values. Renal function impairment (Creatinine value more than 1.2mg/dl or blood urea nitrogen more than 20mg/dl).
Facility Information:
Facility Name
Kasr Al-Ainy Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Aortic Coarcitectomy

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