Pain, AcuteNCT03997019
Erector Spinae Plane Block in Cardiac Surgery
A study testing opioid analgesia and ESP block in people with Pain, Acute, run by Assiut University at 1 site in Egypt.
Trial summary
ultrasound guided bilateral erector spinae plane block will be used as adjuvant to general anaesthesia in cardiac surgery Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- opioid analgesia and ESP block
- 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
- 15 Feb 2019to 15 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- elective surgery
Who cannot join
- emergency
- patient refusal
- infection at or near catheter insertion
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Asyut, 71111
rasha hamed, 01000440773, rashaahmed11@yahoo.com
saeed elsawy, 01030072161, saeedelsawy17@gmail.com
About this study
Official title: Ultrasound Guided Erector Spinae Plane Block in Cardiac Surgery
ultrasound guided bilateral erector spinae plane block will be used as adjuvant to general anaesthesia in cardiac surgery
- Conditions
- Pain, Acute
- Being tested
- opioid analgesia, ESP block
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid analgesiaProcedure or surgery
opioid analgesia will be used with general anaesthesia
ESP blockProcedure or surgery
ultrasound guided ESP Block before anaesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | opioid analgesia Receives: Procedure: opioid analgesia |
| group B | Active comparator | ESP block Receives: Procedure: ESP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
NRS will be used to assess pain
Measured: 48 hours
Secondary outcomes (3)
anaesthesia consumption
cumulative anaesthesia MAC
Measured: 6 hours
ultrasound guided postoperative diaphragmatic excursion
diaphragmatic movement during inspiration an expiration
Measured: 24 hours
spirometric respiratory funtion
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 posted25 Jun 2019
- Study start15 Feb 2019
- Primary completion15 Nov 2020 (estimated)
- Study completion15 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, AcuteStudies 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
- group A WILL RECEIVE OPOID analgesia group B will receive ESP block
- Masking
- Double blind
- Who is masked
- Participant, 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
- NCT03997019
- Sponsor's protocol ID
- FXLD
- Status last verified
- Jun 2019
- First submitted
- 20 Feb 2019
- Last updated
- 25 Jun 2019
- 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 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Plane Block in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03997019
- Acronym / sponsor ID
- FXLD
- Conditions
- Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 25 Jun 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 bilateral erector spinae plane block will be used as adjuvant to general anaesthesia in cardiac surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- group A WILL RECEIVE OPOID analgesia group B will receive ESP block
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: opioid analgesiaopioid analgesia |
| group B | Active comparator | Procedure: ESP blockESP block |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- elective surgery
Key exclusion criteria (3 listed)
- emergency
- patient refusal
- infection at or near catheter insertion
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 |
|---|---|---|
| opioid analgesiaopioid analgesia will be used with general anaesthesia | Procedure or surgery | group A |
| ESP blockultrasound guided ESP Block before anaesthesia induction | Procedure or surgery | group B |
Primary outcome
pain score
Time frame: 48 hours
NRS will be used to assess pain
3 secondary outcomes
anaesthesia consumption
Time frame: 6 hours
ultrasound guided postoperative diaphragmatic excursion
Time frame: 24 hours
spirometric respiratory funtion
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- 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 opioid analgesia and ESP block in people with Pain, Acute, 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 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 25 Jun 2019. 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?
pain 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 25 Jun 2019.