Postoperative PainESPBNCT05769309
Efficacy of Erector Spinae Plane Block Analgesia After Off Pump Cardiac Surgery
A study testing Erector spinae block and Fentanyl in people with Postoperative Pain, run by Menoufia University at 1 site in Egypt.
Trial summary
In this study the investigators will investigate the efficacy of ESPB as a part of Enhanced recovery after surgery on postoperative analgesia and recovery criteria after off pump cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector spinae block and Fentanyl
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Mar 2023to 25 Dec 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-70 years
- ejection fraction of > 45%
- undergoing elective off-pump cardiopulmonary bypass surgery
Who cannot join
- vertebral anomalies
- intra-aortic balloon pump in the preoperative period
- acute myocardial infarction
- local infection at the site of block
- allergy to the local anesthetic used
- morbid obesity, psychiatric disorders, neurologic deficits, alcohol and chronic opioid abuse, and patients with bleeding diathesis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Erector Spinae Plane Block on Postoperative Analgesia and Recovery After Off Pump Cardiac Surgery: A Randomised Trial
In this study the investigators will investigate the efficacy of ESPB as a part of Enhanced recovery after surgery on postoperative analgesia and recovery criteria after off pump cardiac surgery.
Read the detailed description
General anaesthesia will be induced by 0.05 mg/kg midazolam, 3 µg/kg fentanyl, 1-2mg/kg propofol, and 0.5mg/kg of Atracurium. After induction, bilateral erector spinae plane block will be performed in the block group. Intraoperative analgesia will be achieved by fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters. Postoperative analgesia will be managed by paracetamol 1000 mg /6hours and morphine 1-2mg boluses when pain score ≥4 1 to 2 mg to be repeated every 5 minutes if needed.
- Conditions
- Postoperative Pain
- Being tested
- Erector spinae block, Fentanyl
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae blockProcedure or surgery
After induction, the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine
FentanylDrug
fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae block group | Active comparator | the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine Receives: Procedure: Erector spinae block; Drug: Fentanyl |
| control group | Other | no block will be done but only IV analgesia. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative and postoperative opioid consumption
Microgram and mg
Measured: 48 hours
Secondary outcomes (10)
pain intensity at rest and movement
numerical rating score from zero to ten ( 0=no pain, 10 =severe pain )
Measured: 48 hours
time to first rescue analgesia
minutes
Measured: 24hous
Duration of mechanical ventilation
hours
Measured: 24 hours
time to extubation
min
Measured: 24hours
time to ambulation
hours
Measured: 24hours
time to oral intake
hours
Measured: 48 hours
time of chest drain removal
hours
Measured: 5 days
time of intensive care unit stay
hours
Measured: one week
The heart rate
Beats per minutes
Measured: 48 hours
mean arterial blood pressure
mmHg
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 posted15 Mar 2023
- Study start22 Mar 2023
- Primary completion10 Oct 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Gouda Elsayed Safan, Menoufia University
- Investigators
- Islam M ElDesoky, MD, Principal investigator, Menoufia UniversityAMAL G SAFAN, MD, Principal investigator, Menoufia UniversityAbd-Elazeem A Elbakry, MD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769309
- Sponsor's protocol ID
- 2/2023 ANET10-2
- Acronym
- ESPB
- Status last verified
- Mar 2024
- First submitted
- 12 Feb 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Erector Spinae Plane Block on Postoperative Analgesia and Recovery After Off Pump Cardiac Surgery: A Randomised Trial
- ClinicalTrials.gov ID
- NCT05769309
- Acronym / sponsor ID
- ESPB / 2/2023 ANET10-2
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 15 Mar 2023 (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.
In this study the investigators will investigate the efficacy of ESPB as a part of Enhanced recovery after surgery on postoperative analgesia and recovery criteria after off pump cardiac surgery.
Detailed description
General anaesthesia will be induced by 0.05 mg/kg midazolam, 3 µg/kg fentanyl, 1-2mg/kg propofol, and 0.5mg/kg of Atracurium. After induction, bilateral erector spinae plane block will be performed in the block group. Intraoperative analgesia will be achieved by fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters. Postoperative analgesia will be managed by paracetamol 1000 mg /6hours and morphine 1-2mg boluses when pain score ≥4 1 to 2 mg to be repeated every 5 minutes if needed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae block group | Active comparator | Procedure: Erector spinae block, Drug: Fentanylthe patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine |
| control group | Other | Drug: Fentanylno block will be done but only IV analgesia. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-70 years
- ejection fraction of > 45%
- undergoing elective off-pump cardiopulmonary bypass surgery
Key exclusion criteria (6 listed)
- vertebral anomalies
- intra-aortic balloon pump in the preoperative period
- acute myocardial infarction
- local infection at the site of block
- allergy to the local anesthetic used
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 |
|---|---|---|
| Erector spinae blockAfter induction, the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine | Procedure or surgery | Erector spinae block group |
| Fentanylfentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters. | Drug | Erector spinae block group, control group |
Primary outcome
Total intraoperative and postoperative opioid consumption
Time frame: 48 hours
Microgram and mg
10 secondary outcomes
pain intensity at rest and movement
Time frame: 48 hours
time to first rescue analgesia
Time frame: 24hous
Duration of mechanical ventilation
Time frame: 24 hours
time to extubation
Time frame: 24hours
time to ambulation
Time frame: 24hours
time to oral intake
Time frame: 48 hours
time of chest drain removal
Time frame: 5 days
time of intensive care unit stay
Time frame: one week
The heart rate
Time frame: 48 hours
mean arterial blood pressure
Time frame: 48 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 Mar 2024.
- 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.
Islam M ElDesoky, MD principal investigator
Menoufia University
AMAL G SAFAN, MD principal investigator
Menoufia University
Abd-Elazeem A Elbakry, MD principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae block and Fentanyl in people with Postoperative Pain, run by Menoufia 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 3 inclusion and 6 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 Mar 2024. 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?
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?
Total intraoperative and postoperative opioid consumption (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 19 Mar 2024.