Pain, PostoperativeNCT03825068
Erector Spinae Plane Block in Minimal Invasive Cardiac Surgery
A study testing ESP Block and general anesthetic in people with Pain, Postoperative, run by Assiut University at 1 site in Egypt.
Trial summary
Studying the effect of erector spinae plane block in patients undergoing minimal invasive cardiac surgery. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ESP Block and general anesthetic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2018to 30 Nov 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- elective valve replacement
Who cannot join
- chroic renal failure
- chronic liver failure
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut, 71111
mohammed Ali Ahmed, MD, amira_salem2015@yahoo.com
About this study
Studying the effect of erector spinae plane block in patients undergoing minimal invasive cardiac surgery.
- Conditions
- Pain, Postoperative
- Being tested
- ESP Block, general anesthetic
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP BlockProcedure or surgery
20 ml of lacal anaesthetics will be placed below the erector spinae muscle under ultrasound guide
general anestheticDrug
patient receive general anaesthetic only
| Study group | Role | What they receive |
|---|---|---|
| ESP block group | Active comparator | patients receive ESP Bock with local anaesthetics Receives: Procedure: ESP Block |
| control group | Placebo comparator | general anaestesia Receives: Drug: general anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
PAIN SCORES OF PATIENTS
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start15 Nov 2018
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 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
- NCT03825068
- Sponsor's protocol ID
- RRLL
- Status last verified
- Mar 2020
- First submitted
- 30 Jan 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block in Minimal Invasive Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03825068
- Acronym / sponsor ID
- RRLL
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 31 Jan 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.
Studying the effect of erector spinae plane block in patients undergoing minimal invasive cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP block group | Active comparator | Procedure: ESP Blockpatients receive ESP Bock with local anaesthetics |
| control group | Placebo comparator | Drug: general anestheticgeneral anaestesia |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- elective valve replacement
Key exclusion criteria (2 listed)
- chroic renal failure
- chronic liver failure
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 |
|---|---|---|
| ESP Block20 ml of lacal anaesthetics will be placed below the erector spinae muscle under ultrasound guide | Procedure or surgery | ESP block group |
| general anestheticpatient receive general anaesthetic only | Drug | control group |
Primary outcome
VAS
Time frame: 48 hours
PAIN SCORES OF PATIENTS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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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 ESP Block and general anesthetic in people with Pain, Postoperative, 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 1 inclusion and 2 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 10 Mar 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. Some participants in this study may receive a placebo. 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?
Contact rasha hamed, lecturer (01000440773, rashaahmed11@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (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 10 Mar 2020.