The Effect of Paravertebral Block With Dexamethasone on Intraoperative and Postoperative Analgesia in Children Undergoing Surgery for Coarctation of Aorta
Paravertebral Block in Coarctation of the Aorta
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2016
CompletedFirst Submitted
Initial submission to the registry
February 24, 2017
CompletedFirst Posted
Study publicly available on registry
March 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2017
CompletedJuly 19, 2017
July 1, 2017
5 months
February 24, 2017
July 18, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Intraoperative fentanyl needs
total fentanyl consumption intraoperatively
3hours
postoperative analgesic requirements
total narcotic consumption
24hours
Secondary Outcomes (2)
the first time the analgesic required
24 hours
extubation time
24 hours
Study Arms (2)
paravertebral block with bupivacaine
ACTIVE COMPARATORthis group will receive 0.5mg/kg bupivacaine 0.25% diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively
paravertebral block with bupivacaine and dexamethasone
ACTIVE COMPARATORthis 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
Interventions
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
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
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.
it is an amino amide local anesthetic drug
sterile sodium chloride solution at physiological concentration (0.87%); used as diluting agent when added to local anesthetic drug
Eligibility Criteria
You may qualify if:
- m-6 years males and females scheduled for surgery for coarctation of the aorta
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Amany Hassan Saleh
Cairo, 02, Egypt
Related Publications (1)
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.
PMID: 30501611DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
kasr alaini hospital
Cairo University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecture of anethesia, Cairo university
Study Record Dates
First Submitted
February 24, 2017
First Posted
March 9, 2017
Study Start
October 30, 2016
Primary Completion
March 30, 2017
Study Completion
April 15, 2017
Last Updated
July 19, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share