AnalgesiaNCT07692659
Ultrasound-Guided Parasternal/Rectus Sheath Block vs Erector Spinae Plane Block for Pain Control in Cardiac Surgery
A study testing Parasternal/ Rectus sheath block and Erector spinae plane block in people with Analgesia and Perioperative Analgesia, run by National Cancer Institute, Egypt.
Trial summary
The researchers are working to improve recovery after heart surgery by reducing reliance on opioids. Newer regional anesthesia techniques can provide strong pain relief with fewer risks, but the choice of method depends on each patient's condition, medications, and surgical plan Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Perioperative Analgesia, Regional Block Technique
- What is being tested?
- Parasternal/ Rectus sheath block and Erector spinae plane block
- 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
- No sites listed yet
- Study dates
- Jul 2026to Jun 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
- Both sexes,
- ASA III-IV patients
- body mass index between 20- 35 kg/m2
- adult patients above 18 years old will be included in the study
Who cannot join
- Patients with global hypokinesia
- ejection fraction < 40%
- low platelet count
- coagulation impairment
- deformity in the vertebral column
- severe renal and hepatic impairment
- any known allergy to the drugs used
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Ultrasound Guided Bilateral Parasternal Block With Bilateral Rectus Sheath Block Versus Ultrasound Guided Bilateral Erector Spinae Plane Block in Controlling Intra and Post-operative Pain After Cardiac Surgeries
The researchers are working to improve recovery after heart surgery by reducing reliance on opioids. Newer regional anesthesia techniques can provide strong pain relief with fewer risks, but the choice of method depends on each patient's condition, medications, and surgical plan
Read the detailed description
Optimal anesthesia in cardiac surgery requires careful management to avoid sympathetic stimulation, with analgesia being central to patient safety and recovery. Traditionally, high-dose opioids were used, but this approach delays extubation, conflicting with fast-track protocols that emphasize early extubation. Consequently, opioid-free analgesia has gained importance, employing regional techniques such as neuraxial, paravertebral, and fascial plane blocks.
Thoracic epidural analgesia (TEA) offers effective pain control and reduces perioperative cardiovascular and respiratory complications. However, its use in anticoagulated patients raises concern for epidural hematoma. Alternatives like paravertebral and fascial plane blocks provide comparable analgesia with lower risk. The erector spinae plane block (ESPB) reduces analgesic requirements, though deep blocks still pose bleeding risks.
Superficial plane blocks are therefore clinically valuable. The parasternal intercostal block-targeting anterior cutaneous branches of intercostal nerves-has emerged as a safe option for patients undergoing median sternotomy while on anticoagulant or antiplatelet therapy. Additionally, bilateral rectus sheath block can reduce chest tube insertion pain after cardiac surgery.
- Conditions
- Analgesia, Perioperative Analgesia, Regional Block Technique
- Being tested
- Parasternal/ Rectus sheath block, Erector spinae plane block
- Keywords
- Parasternal block; Rectus sheath block; ESPB; Analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasternal/ Rectus sheath blockProcedure or surgery
the parasternal block will be performed parasternally at the level of fifth rib to the plane between the pectoralis major and the internal intercostal muscle. The rectus sheath block will be performed through injection in the plane posterior to the rectus abdominis muscle and anterior to the posterior rectus sheath
Erector spinae plane blockProcedure or surgery
injection above the transverse process
| Study group | Role | What they receive |
|---|---|---|
| Parasternal/ Rectus sheath | Experimental | Patients will receive Parasternal and rectus sheath blocks; with injection of 10 ml bupivacaine 0.25% in each side after confirmation of needle position. Both parasternal and rectus heath blocks will be performed bilaterally Receives: Procedure: Parasternal/ Rectus sheath block |
| Erector Spinae Plane Block | Experimental | The patients will receive a bilateral ESPB with an injection of 20 ml of bupivacaine 0.25%. Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating score
postoperative pain scores using Numerical Rating Scale (NRS) with 0 meaning no pain and 10 meaning the worst pain level
Measured: 24 hours
Secondary outcomes (4)
postoperative opioid consumption
opioid consumption in the first 24 hours postoperatively
Measured: 24 hours
extubation time
time to extubate
Measured: immediate postoperative
first time to request analgesia
first time to request opioid analgesia
Measured: 24 hours
peri-operative hemodynamics
incidence of hypotension, hypertension, tachycardia and bradycardia
Measured: intraoperative and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 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
- Model description
- 2
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Saudi German Hospital - Madinah
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- Walaa Y Elsabeeny, MD, Principal investigator, A Professor of Anesthesia, Critical Care and Pain Management, National Cancer Institute, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692659
- Sponsor's protocol ID
- ECC-2025-64
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Guided Bilateral Parasternal Block With Bilateral Rectus Sheath Block Versus Ultrasound Guided Bilateral Erector Spinae Plane Block in Controlling Intra and Post-operative Pain After Cardiac Surgeries
- ClinicalTrials.gov ID
- NCT07692659
- Acronym / sponsor ID
- ECC-2025-64
- Conditions
- Analgesia, Perioperative Analgesia, Regional Block Technique
- Keywords
- Parasternal block; Rectus sheath block; ESPB; Analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Collaborators
- Saudi German Hospital - Madinah
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Jul 2026 (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.
The researchers are working to improve recovery after heart surgery by reducing reliance on opioids. Newer regional anesthesia techniques can provide strong pain relief with fewer risks, but the choice of method depends on each patient's condition, medications, and surgical plan
Detailed description
Optimal anesthesia in cardiac surgery requires careful management to avoid sympathetic stimulation, with analgesia being central to patient safety and recovery. Traditionally, high-dose opioids were used, but this approach delays extubation, conflicting with fast-track protocols that emphasize early extubation. Consequently, opioid-free analgesia has gained importance, employing regional techniques such as neuraxial, paravertebral, and fascial plane blocks.
Thoracic epidural analgesia (TEA) offers effective pain control and reduces perioperative cardiovascular and respiratory complications. However, its use in anticoagulated patients raises concern for epidural hematoma. Alternatives like paravertebral and fascial plane blocks provide comparable analgesia with lower risk. The erector spinae plane block (ESPB) reduces analgesic requirements, though deep blocks still pose bleeding risks.
Superficial plane blocks are therefore clinically valuable. The parasternal intercostal block-targeting anterior cutaneous branches of intercostal nerves-has emerged as a safe option for patients undergoing median sternotomy while on anticoagulant or antiplatelet therapy. Additionally, bilateral rectus sheath block can reduce chest tube insertion pain after cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2
| Arm | Type | Receives |
|---|---|---|
| Parasternal/ Rectus sheath | Experimental | Procedure: Parasternal/ Rectus sheath blockPatients will receive Parasternal and rectus sheath blocks; with injection of 10 ml bupivacaine 0.25% in each side after confirmation of needle position. Both parasternal and rectus heath blocks will be performed bilaterally |
| Erector Spinae Plane Block | Experimental | Procedure: Erector spinae plane blockThe patients will receive a bilateral ESPB with an injection of 20 ml of bupivacaine 0.25%. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both sexes,
- ASA III-IV patients
- body mass index between 20- 35 kg/m2
- adult patients above 18 years old will be included in the study
Key exclusion criteria (7 listed)
- Patients with global hypokinesia
- ejection fraction < 40%
- low platelet count
- coagulation impairment
- deformity in the vertebral column
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 |
|---|---|---|
| Parasternal/ Rectus sheath blockthe parasternal block will be performed parasternally at the level of fifth rib to the plane between the pectoralis major and the internal intercostal muscle. The rectus sheath block will be performed through injection in the plane posterior to the rectus abdominis muscle and anterior to the posterior rectus sheath | Procedure or surgery | Parasternal/ Rectus sheath |
| Erector spinae plane blockinjection above the transverse process | Procedure or surgery | Erector Spinae Plane Block |
Primary outcome
Numeric rating score
Time frame: 24 hours
postoperative pain scores using Numerical Rating Scale (NRS) with 0 meaning no pain and 10 meaning the worst pain level
4 secondary outcomes
postoperative opioid consumption
Time frame: 24 hours
extubation time
Time frame: immediate postoperative
first time to request analgesia
Time frame: 24 hours
peri-operative hemodynamics
Time frame: intraoperative and 24 hours
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 13 Jul 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.
Walaa Y Elsabeeny, MD principal investigator
A Professor of Anesthesia, Critical Care and Pain Management, National Cancer Institute, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Parasternal/ Rectus sheath block and Erector spinae plane block in people with Analgesia and Perioperative Analgesia, run by National Cancer Institute, 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Walaa Y Elsabeeny, MD (01007798466, walaa.elsabeeny@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating score (time frame: 24 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 13 Jul 2026.