Coarctation of AortaPhase 1NCT03074773
The Effect of Paravertebral Block With Dexamethasone on Intraoperative and Postoperative Analgesia in Children Undergoing Surgery for Coarctation of Aorta
A Phase 1 study testing Dexamethasone, ultrasound and paravertebral block in people with Coarctation of Aorta, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 months to 6 years
- Conditions the study is for
- Coarctation of Aorta
- What is being tested?
- Dexamethasone, ultrasound and paravertebral block
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2016to 15 Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 4m-6 years males and females scheduled for surgery for coarctation of the aorta
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paravertebral Block in Coarctation of the Aorta
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.
Read the 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.
- Conditions
- Coarctation of Aorta
- Being tested
- Dexamethasone, ultrasound, paravertebral block, Bupivacaine, isotonic saline
- Medical subject headings
- Aortic Coarctation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called decadron
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
ultrasoundDevice
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 blockProcedure or surgery
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.
BupivacaineDrug
Also called marcain
it is an amino amide local anesthetic drug
isotonic salineOther
Also called normal saline
sterile sodium chloride solution at physiological concentration (0.87%); used as diluting agent when added to local anesthetic drug
| Study group | Role | What they receive |
|---|---|---|
| paravertebral block with bupivacaine | Active comparator | this group will receive 0.5mg/kg bupivacaine 0.25% diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively Receives: Device: ultrasound; Procedure: paravertebral block; Drug: Bupivacaine; Other: isotonic saline |
| paravertebral block with bupivacaine and dexamethasone | Active comparator | 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 Receives: Drug: Dexamethasone; Device: ultrasound; Procedure: paravertebral block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative fentanyl needs
total fentanyl consumption intraoperatively
Measured: 3hours
postoperative analgesic requirements
total narcotic consumption
Measured: 24hours
Secondary outcomes (2)
the first time the analgesic required
the time of narcotics need
Measured: 24 hours
extubation time
postoperative extubation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start30 Oct 2016
- Primary completion30 Mar 2017
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coarctation of AortaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Hassan Saleh, Cairo University
- Investigators
- kasr alaini hospital, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074773
- Sponsor's protocol ID
- N-81-2016
- Status last verified
- Jul 2017
- First submitted
- 24 Feb 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30501611
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Block in Coarctation of the Aorta
- ClinicalTrials.gov ID
- NCT03074773
- Acronym / sponsor ID
- N-81-2016
- Conditions
- Coarctation of Aorta
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Oct 2016 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paravertebral block with bupivacaine | Active comparator | Device: ultrasound, Procedure: paravertebral block, Drug: Bupivacaine, Other: isotonic salinethis 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 comparator | Drug: Dexamethasone, Device: ultrasound, Procedure: paravertebral block, Drug: Bupivacainethis 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 |
Who may qualify
- Ages
- 4 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 4m-6 years males and females scheduled for surgery for coarctation of the aorta
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: decadronDexamethasone 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 | Drug | paravertebral block with bupivacaine and dexamethasone |
| ultrasoundThe 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 | Device | paravertebral block with bupivacaine, paravertebral block with bupivacaine and dexamethasone |
| paravertebral blockparavertebral 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. | Procedure or surgery | paravertebral block with bupivacaine, paravertebral block with bupivacaine and dexamethasone |
| BupivacaineAlso: marcainit is an amino amide local anesthetic drug | Drug | paravertebral block with bupivacaine, paravertebral block with bupivacaine and dexamethasone |
| isotonic salineAlso: normal salinesterile sodium chloride solution at physiological concentration (0.87%); used as diluting agent when added to local anesthetic drug | Other | paravertebral block with bupivacaine |
Primary outcome
Intraoperative fentanyl needs
Time frame: 3hours
total fentanyl consumption intraoperatively
postoperative analgesic requirements
Time frame: 24hours
total narcotic consumption
2 secondary outcomes
the first time the analgesic required
Time frame: 24 hours
extubation time
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Derived from this study: PubMed 30501611Saleh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kasr alaini hospital study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone, ultrasound and paravertebral block in people with Coarctation of Aorta, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative fentanyl needs (time frame: 3hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03074773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.