Pain ManagementNCT04168177
Bilateral Erector Spinae Plane Block in Paediateric Cardiac Surgery
A study testing PCA and ESP in people with Pain Management, run by Assiut University at 1 site in Egypt.
Trial summary
ultrasound guided erector spinae plane block will be done for childern under going midline sternotomy for cardiac surgery. It is a novel block which is suspected to give powerful analgesia, decrease anaesthetic consumption and decrease awareness on cardiac bypass Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Pain Management
- What is being tested?
- PCA and ESP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Feb 2019to 20 Dec 2020
- Phase
- Interventional
- 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 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- elective surgery
- childern between 4 and 10 years
Who cannot join
- emergency
- infection at injection site
- allergy to local anaestheics
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut, 71111
rasha hamed, MD, 0882413201, rashaahmed11@yahoo.nom
About this study
Official title: Bilateral Erector Spinae Plane Block in Paediateric Cardiac Surgery, Randomized Study
ultrasound guided erector spinae plane block will be done for childern under going midline sternotomy for cardiac surgery. It is a novel block which is suspected to give powerful analgesia, decrease anaesthetic consumption and decrease awareness on cardiac bypass
- Conditions
- Pain Management
- Being tested
- PCA, ESP
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCAProcedure or surgery
Patient controlled analgesia
ESPProcedure or surgery
erector spinae plane block
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Not described Receives: Procedure: PCA |
| ESP Group | Active comparator | Not described Receives: Procedure: ESP |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue score
pain scores will be assessed by anaesthesia and ICU nurse. zero mean no pain an 10 indicate the worst pain.
Measured: 48 hours
Secondary outcomes (1)
intraoperative anaesthetic consumption
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start17 Feb 2019
- Primary completion17 Jul 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients will be randomly assigned into one of two groups, control group will receive patient controlled analgesia, and intervention group will receive ESP Block .
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168177
- Sponsor's protocol ID
- ASDF
- Status last verified
- Jun 2020
- First submitted
- 20 Feb 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Erector Spinae Plane Block in Paediateric Cardiac Surgery, Randomized Study
- ClinicalTrials.gov ID
- NCT04168177
- Acronym / sponsor ID
- ASDF
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 17 Feb 2019 (actual)
- Primary completion
- 17 Jul 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 19 Nov 2019 (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.
ultrasound guided erector spinae plane block will be done for childern under going midline sternotomy for cardiac surgery. It is a novel block which is suspected to give powerful analgesia, decrease anaesthetic consumption and decrease awareness on cardiac bypass
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- patients will be randomly assigned into one of two groups, control group will receive patient controlled analgesia, and intervention group will receive ESP Block .
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: PCA |
| ESP Group | Active comparator | Procedure: ESP |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- elective surgery
- childern between 4 and 10 years
Key exclusion criteria (3 listed)
- emergency
- infection at injection site
- allergy to local anaestheics
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 |
|---|---|---|
| PCAPatient controlled analgesia | Procedure or surgery | control group |
| ESPerector spinae plane block | Procedure or surgery | ESP Group |
Primary outcome
visual analogue score
Time frame: 48 hours
pain scores will be assessed by anaesthesia and ICU nurse. zero mean no pain an 10 indicate the worst pain.
1 secondary outcome
intraoperative anaesthetic consumption
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCA and ESP in people with Pain Management, run by Assiut 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Jun 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue score (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2020.