The Effect of Paravertebral Block With Dexamethasone on Intraoperative and Postoperative Analgesia in Children Undergoing Surgery for Coarctation of Aorta
Primary Purpose
Coarctation of Aorta
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone
ultrasound
paravertebral block
Bupivacaine
isotonic saline
Sponsored by
About this trial
This is an interventional health services research trial for Coarctation of Aorta
Eligibility Criteria
Inclusion Criteria:
- 4m-6 years males and females scheduled for surgery for coarctation of the aorta
Exclusion Criteria:
- patients with associated other cardiac anomalies (e.g. VSD), patients with airway abnormality, patients with heart failure, patients with endocrine disorders, patients with history of convulsions, neurological disorder, hepatic, renal and neuromuscular diseases, coagulopathy, history of hyperthermia, infection at site of the block and family history of hypersensitivity
Sites / Locations
- Amany Hassan Saleh
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
paravertebral block with bupivacaine
paravertebral block with bupivacaine and dexamethasone
Arm Description
this group will receive 0.5mg/kg bupivacaine 0.25% diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively
this group will receive 0.5mg/kg bupivacaine 0.25% mixed to 0.1 mg/kg dexamethasone diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively
Outcomes
Primary Outcome Measures
Intraoperative fentanyl needs
total fentanyl consumption intraoperatively
postoperative analgesic requirements
total narcotic consumption
Secondary Outcome Measures
the first time the analgesic required
the time of narcotics need
extubation time
postoperative extubation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03074773
Brief Title
The Effect of Paravertebral Block With Dexamethasone on Intraoperative and Postoperative Analgesia in Children Undergoing Surgery for Coarctation of Aorta
Official Title
Paravertebral Block in Coarctation of the Aorta
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 30, 2016 (Actual)
Primary Completion Date
March 30, 2017 (Actual)
Study Completion Date
April 15, 2017 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Anesthetic management for surgery of aortic coarctation needs special care due to severe pain during lateral thoracotomy incision, the intraoperative hemodynamic instability related to skin incision at lateral thoracotomy, clamping and declamping of the aorta, needs of large doses of analgesia perioperative, needs of vasodilators. Also, postoperative care of the patients after repair is very important issue. The investigators will compare the effect of para-vertebral block with bupivacaine alone or with dexamethasone on Intra and postoperative analgesia.
Detailed Description
The patients will be divided randomly by sealed envelope into 2 equal groups. Group I (n=30) will receive paravertebral block with 0.5mg/kg bupivacaine 0.25% diluted with isotonic saline (total volume 15ml) and group II (n=30) will receive paravertebral block with 0.5mg/kg 0.25% bupivacaine and 0.1mg/kg dexamethasone.intraoperative fentanyl needs, Intra and postoperative hemodynamics and OPS pain scores will be recorded. Possible risks as hypertension will be treated by nitroglycerin infusion 0.5ug/kg/min or tachycardia (HR more than 20% than baseline) will be managed by additional doses of fentanyl 1-2ug/kg, bradycardia (20% decrease from the baseline) will be managed by atropine 0.02mg/kg. Also, the complications of paravertebral block as peridural and intravascular injection can be avoided by careful aspiration before injection and injection while visualization of the needle by U/S.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coarctation of Aorta
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
paravertebral block with bupivacaine
Arm Type
Active Comparator
Arm Description
this group will receive 0.5mg/kg bupivacaine 0.25% diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively
Arm Title
paravertebral block with bupivacaine and dexamethasone
Arm Type
Active Comparator
Arm Description
this group will receive 0.5mg/kg bupivacaine 0.25% mixed to 0.1 mg/kg dexamethasone diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
decadron
Intervention Description
Dexamethasone is commonly used in the perioperative period to reduce postoperative nausea and vomiting. Additionally, it has been reported to have analgesic effects.
The analgesic effect of epidural or perineural dexamethasone administration is not clear. Dexamethasone might have a local anesthetic effect on nerve by direct membrane action
Intervention Type
Device
Intervention Name(s)
ultrasound
Intervention Description
The growth of ultrasound technology and, with it, our ability to visualize the pleura and other structures in and around the paravertebral space has fueled a tremendous increased interest in performing thoracic paravertebral blocks. These blocks may be used for acute pain control, as an adjunct to general anesthesia for peri-operative pain control and, in some practices, as the primary anesthetic
Intervention Type
Procedure
Intervention Name(s)
paravertebral block
Intervention Description
paravertebral block is an effective analgesic technique used in various types of surgery, trauma and chronic pain. it decreases postoperative pain and reduces opioid consumption which in turns improve postoperative pulmonary function hoping for early extubation.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
marcain
Intervention Description
it is an amino amide local anesthetic drug
Intervention Type
Other
Intervention Name(s)
isotonic saline
Other Intervention Name(s)
normal saline
Intervention Description
sterile sodium chloride solution at physiological concentration (0.87%); used as diluting agent when added to local anesthetic drug
Primary Outcome Measure Information:
Title
Intraoperative fentanyl needs
Description
total fentanyl consumption intraoperatively
Time Frame
3hours
Title
postoperative analgesic requirements
Description
total narcotic consumption
Time Frame
24hours
Secondary Outcome Measure Information:
Title
the first time the analgesic required
Description
the time of narcotics need
Time Frame
24 hours
Title
extubation time
Description
postoperative extubation
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
4m-6 years males and females scheduled for surgery for coarctation of the aorta
Exclusion Criteria:
patients with associated other cardiac anomalies (e.g. VSD), patients with airway abnormality, patients with heart failure, patients with endocrine disorders, patients with history of convulsions, neurological disorder, hepatic, renal and neuromuscular diseases, coagulopathy, history of hyperthermia, infection at site of the block and family history of hypersensitivity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kasr alaini hospital
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Amany Hassan Saleh
City
Cairo
ZIP/Postal Code
02
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30501611
Citation
Saleh AH, Hassan PF, Elayashy M, Hamza HM, Abdelhamid MH, Madkour MA, Tawadros PZ, Omar H, Kamel MM, Zayed M, Helmy M. Role of dexamethasone in the para-vertebral block for pediatric patients undergoing aortic coarctation repair. randomized, double-blinded controlled study. BMC Anesthesiol. 2018 Nov 30;18(1):178. doi: 10.1186/s12871-018-0637-y.
Results Reference
derived
Learn more about this trial
The Effect of Paravertebral Block With Dexamethasone on Intraoperative and Postoperative Analgesia in Children Undergoing Surgery for Coarctation of Aorta
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