AnalgesiaNCT05763810
Comparing Different Regional Blocks for Analgesia After Off-pump Cardiac Surgery
A study testing Erector Spinae Plane Block and Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath Block in people with Analgesia, run by Amal Gouda Elsayed Safan at 1 site in Egypt.
Trial summary
This study aims to compare the analgesic effects of erector spinae plane block versus Superficial Parasternal Intercostal Plane Block block along with rectus sheath block after off-pump cardiac surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Erector Spinae Plane Block and Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2023to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of anaesthesiologists physical status classification II-III
- Elective off-pump cardiac surgery
Who cannot join
- Cognitive impairment
- Allergy to local anaesthetics
- Renal and/or hepatic dysfunction
- Ejection fraction< 45%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Effects of Erector Spinae Plane Block Versus Superficial Parasternal Intercostal Plane Block Combined With Rectus Sheath Block After Off Pump Cardiac Surgery: A Randomised Trial
This study aims to compare the analgesic effects of erector spinae plane block versus Superficial Parasternal Intercostal Plane Block block along with rectus sheath block after off-pump cardiac surgery
Read the detailed description
General anaesthesia will be used for all patients. induction by midazolam 0.05-0.1 mg/kg, fentanyl 2-5 µ/kg, propofol 1-2 mg/kg, and atracurium 0.5 mg/kg for intubation. Maintenance by sevoflurane in oxygen-air mixture. regional blocks will be used after the induction of anaesthesia. Intraoperative analgesia will be maintained by fentanyl infusion 1-2 µ/kg/h while morphine sulphate 2.5-5mg will be used as rescue analgesia when pain score>4 beside acetaminophen 1000 mg /6 hours
- Conditions
- Analgesia
- Being tested
- Erector Spinae Plane Block, Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockOther
Erector Spinae Plane Block
Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath BlockOther
Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath Block
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block group | Other | Erector Spinae Plane Block Receives: Other: Erector Spinae Plane Block |
| Superficial Parasternal Intercostal Plane Block and Rectus Sheath Block group | Other | Superficial Parasternal Intercostal Plane Block and Rectus Sheath Block Receives: Other: Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
µg and mg
Measured: Perioperative.
Secondary outcomes (6)
Pain intensity at rest and exercise
Visual analogue score: a score from 0 to 10(0= no pain and 10 the worst imaginable pain)
Measured: Perioperative.
Extubation time
minutes
Measured: Perioperative
Duration of post anaesthesia care unit stay
minutes
Measured: Perioperative
Postoperative nausea
number (%)
Measured: Perioperative
Postoperative vomiting
number (%)
Measured: Perioperative
Duration of hospital stay
days
Measured: Postoperative up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start15 Mar 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amal Gouda Elsayed Safan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amal Gouda Elsayed Safan, Menoufia University
- Investigators
- Abd-Elazeem A Elbakry, MD, Principal investigator, Menoufia UniversityAmal G Safan, MD, Principal investigator, Menoufia UniversityIslam M El-Desoky, MD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763810
- Sponsor's protocol ID
- 2/2023 ANET 15-3
- Status last verified
- Oct 2026
- First submitted
- 28 Feb 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effects of Erector Spinae Plane Block Versus Superficial Parasternal Intercostal Plane Block Combined With Rectus Sheath Block After Off Pump Cardiac Surgery: A Randomised Trial
- ClinicalTrials.gov ID
- NCT05763810
- Acronym / sponsor ID
- 2/2023 ANET 15-3
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Amal Gouda Elsayed SafanUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 10 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.
This study aims to compare the analgesic effects of erector spinae plane block versus Superficial Parasternal Intercostal Plane Block block along with rectus sheath block after off-pump cardiac surgery
Detailed description
General anaesthesia will be used for all patients. induction by midazolam 0.05-0.1 mg/kg, fentanyl 2-5 µ/kg, propofol 1-2 mg/kg, and atracurium 0.5 mg/kg for intubation. Maintenance by sevoflurane in oxygen-air mixture. regional blocks will be used after the induction of anaesthesia. Intraoperative analgesia will be maintained by fentanyl infusion 1-2 µ/kg/h while morphine sulphate 2.5-5mg will be used as rescue analgesia when pain score>4 beside acetaminophen 1000 mg /6 hours
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block group | Other | Other: Erector Spinae Plane BlockErector Spinae Plane Block |
| Superficial Parasternal Intercostal Plane Block and Rectus Sheath Block group | Other | Other: Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath BlockSuperficial Parasternal Intercostal Plane Block and Rectus Sheath Block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of anaesthesiologists physical status classification II-III
- Elective off-pump cardiac surgery
Key exclusion criteria (4 listed)
- Cognitive impairment
- Allergy to local anaesthetics
- Renal and/or hepatic dysfunction
- Ejection fraction< 45%
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 Plane BlockErector Spinae Plane Block | Other | Erector Spinae Plane Block group |
| Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath BlockSuperficial Parasternal Intercostal Plane Block combined with Rectus Sheath Block | Other | Superficial Parasternal Intercostal Plane Block and Rectus Sheath Block group |
Primary outcome
Total opioid consumption
Time frame: Perioperative.
µg and mg
6 secondary outcomes
Pain intensity at rest and exercise
Time frame: Perioperative.
Extubation time
Time frame: Perioperative
Duration of post anaesthesia care unit stay
Time frame: Perioperative
Postoperative nausea
Time frame: Perioperative
Postoperative vomiting
Time frame: Perioperative
Duration of hospital stay
Time frame: Postoperative up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
Abd-Elazeem A Elbakry, MD principal investigator
Menoufia University
Amal G Safan, MD principal investigator
Menoufia University
Islam M El-Desoky, 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 Plane Block and Superficial Parasternal Intercostal Plane Block combined with Rectus Sheath Block in people with Analgesia, run by Amal Gouda Elsayed Safan 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 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 opioid consumption (time frame: Perioperative.). 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 26 Oct 2026.