Effect of Dexamethasone as an Adjuvant to Bupivacaine in Bilateral Erector Spinae Block on Postoperative Pain and Diaphragmatic Function After Pediatric Cardiac Surgeries : A Randomized Controlled Clinical Trial
Primary Purpose
Pediatric Cardiac Surgery
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bilateral erector spinae plane block in pediatric cardiac surgeries
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Cardiac Surgery
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I and II
- Undergoing cardiac surgical procedures through a midline sternotomyPreoperative ejection fraction <35%
Exclusion Criteria:
- Low-cardiac-output syndrome
- Ventricular arrhythmia
- Preoperative inotropic support
- Known allergies to any of the study drugs
- Intubation for more than 3 hours or re-exploration
- A redo or emergency surgery
- Contraindications to regional anesthesia as coagulopathy and infection in site of block.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
group A
Group B
Group C
Arm Description
bilateral ESPB with 0.5 ml/kg of 0.25% bupivacaine (limited to a maximum dose of 20 ml) for each side
bilateral ESPB with 0.5 ml/kg of 0.25% bupivacaine (limited to a maximum dose of 20 ml) + dexamethasone 0.1 mg/kg for each side
control group will receive the standard analgesic regimen only
Outcomes
Primary Outcome Measures
postoperative pain, Face, Legs, Activity, Cry and Consolability (FLACC) pain scale
The primary outcome of this study is the intensity of postoperative pain that will be assessed using Face, Legs, Activity, Cry and Consolability, minimum value 0 and maximum value 10, high scores means worse outcome (FLACC) pain scale
Secondary Outcome Measures
total analgesic consumption postoperative
total amount of postoperative analgesic consumption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05536063
Brief Title
Effect of Dexamethasone as an Adjuvant to Bupivacaine in Bilateral Erector Spinae Block on Postoperative Pain and Diaphragmatic Function After Pediatric Cardiac Surgeries : A Randomized Controlled Clinical Trial
Official Title
Effect of Dexamethasone as an Adjuvant to Bupivacaine in Bilateral Erector Spinae Block on Postoperative Pain and Diaphragmatic Function After Pediatric Cardiac Surgeries : A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to figure out the efficacy of dexamethasone addition to bupivacaine versus bupivacaine alone in bilateral erector spinae plane block on postoperative analgesia after pediatric cardiac surgeries
Detailed Description
The recently introduced ultrasound-guided interfascial plane block, bilateral erector spinae plane block (ESPB) is a viable option for management of postoperative pain after midline sternotomy. It is expected to provide an analgesic cover spanning the entire thorax at the desired dermatomes including the midline, which could prove beneficial for cardiac surgery through midline sternotomy.
Indications for ESPB for postoperative analgesia in pediatric surgeries to date include thoracotomy, video-assisted thoracoscopic surgery, vascular ring repair and sternotomy.
Dexamethasone is a synthetic glucocorticoid acting as an anti- inflammatory. It inhibits the release of inflammatory mediators such as interleukins and cytokines. Several studies have shown that a preoperative dose of dexamethasone added to local anesthetic agents has promising results in reducing postoperative pain and improving the quality of analgesia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Cardiac Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
bilateral ESPB with 0.5 ml/kg of 0.25% bupivacaine (limited to a maximum dose of 20 ml) for each side
Arm Title
Group B
Arm Type
Experimental
Arm Description
bilateral ESPB with 0.5 ml/kg of 0.25% bupivacaine (limited to a maximum dose of 20 ml) + dexamethasone 0.1 mg/kg for each side
Arm Title
Group C
Arm Type
No Intervention
Arm Description
control group will receive the standard analgesic regimen only
Intervention Type
Procedure
Intervention Name(s)
bilateral erector spinae plane block in pediatric cardiac surgeries
Intervention Description
The ESPB will be performed after induction of anesthesia, endotracheal tube insertion and before the start of operation, with the child in a right lateral decubitus position under aseptic precautions. A high frequency linear ultrasound transducer will be placed over the T4 transverse process lateral to the spinous process. After identifying the muscles above the hyperechoic transverse process image, a 5-cm 22 gauge needle will be inserted in-plane in a cephalo-caudad direction. The endpoint is defined as the needle pointing to the tip of transverse process piercing the erector spinae muscle. The local anesthetic will be deposited at this position, After careful negative aspiration, local anesthetic, according to study groups , The process will be repeated on thecontralateral side
Primary Outcome Measure Information:
Title
postoperative pain, Face, Legs, Activity, Cry and Consolability (FLACC) pain scale
Description
The primary outcome of this study is the intensity of postoperative pain that will be assessed using Face, Legs, Activity, Cry and Consolability, minimum value 0 and maximum value 10, high scores means worse outcome (FLACC) pain scale
Time Frame
Postoperative pain assessment is performed using FLACC pain scale at fixed time intervasl for 48 hours post extubation,
Secondary Outcome Measure Information:
Title
total analgesic consumption postoperative
Description
total amount of postoperative analgesic consumption
Time Frame
for 48 hours postextubation
Other Pre-specified Outcome Measures:
Title
Beta endorphins levels
Description
comparison between preoperative and postoperative levels of B-endorphins
Time Frame
Blood samples for postoperative beta-endorphins at 2, 24, and 48 hours post-extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) physical status I and II
Undergoing cardiac surgical procedures through a midline sternotomyPreoperative ejection fraction <35%
Exclusion Criteria:
Low-cardiac-output syndrome
Ventricular arrhythmia
Preoperative inotropic support
Known allergies to any of the study drugs
Intubation for more than 3 hours or re-exploration
A redo or emergency surgery
Contraindications to regional anesthesia as coagulopathy and infection in site of block.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amonios khalil, assistan lecturer
Phone
01023466456
Email
amonios_khalil@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
35489304
Citation
Karacaer F, Biricik E, Ilginel M, Tunay D, Topcuoglu S, Unlugenc H. Bilateral erector spinae plane blocks in children undergoing cardiac surgery: A randomized, controlled study. J Clin Anesth. 2022 Sep;80:110797. doi: 10.1016/j.jclinane.2022.110797. Epub 2022 Apr 28.
Results Reference
background
PubMed Identifier
24949192
Citation
Ferrari G, De Filippi G, Elia F, Panero F, Volpicelli G, Apra F. Diaphragm ultrasound as a new index of discontinuation from mechanical ventilation. Crit Ultrasound J. 2014 Jun 7;6(1):8. doi: 10.1186/2036-7902-6-8. eCollection 2014.
Results Reference
background
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Effect of Dexamethasone as an Adjuvant to Bupivacaine in Bilateral Erector Spinae Block on Postoperative Pain and Diaphragmatic Function After Pediatric Cardiac Surgeries : A Randomized Controlled Clinical Trial
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