Breast SurgeryNCT06989372
Serratus Posterior Superior Intercostal Plane Block, Versus Erector Spinae Facial Plane Blocks
A study testing serratus posterior superior block and erector spinae block in people with Breast Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
Mastectomy is currently the most effective treatment for breast cancers in women. postoperative pain management carries a high degree of difficulty, as the breast has complex innervation involving the intercostal (T1-T7), superficial cervical plexus (supraclavicular nerves) and brachial plexus .While severe acute pain… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Surgery
- What is being tested?
- serratus posterior superior block and erector spinae block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Sep 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 to 65 years
- ASA classification I and II
Who cannot join
- age below 18 or above 65 years
- ASA classification III or more
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Serratus Posterior Superior Intercostal Plane Block, Versus Erector Spinae Facial Plane Blocks A Comparative Study for Postoperative Pain Control and Opioid Consumption for Patient Undergoing Modified Radical Mastectomy Surgery
Mastectomy is currently the most effective treatment for breast cancers in women. postoperative pain management carries a high degree of difficulty, as the breast has complex innervation involving the intercostal (T1-T7), superficial cervical plexus (supraclavicular nerves) and brachial plexus .While severe acute pain is observed in approximately 40% of post-mastectomy patients, moderate-to-severe pain is observed in almost one-third of them .
- Conditions
- Breast Surgery
- Being tested
- serratus posterior superior block, erector spinae block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus posterior superior blockProcedure or surgery
patients were placed in the lateral decubitus position for SPSIPB. The blocks were performed under the guidance of ultrasonography (USG), a high-frequency linear probe (SonoSite HFL50x, 15-6 MHz, 55-mm broadband linear array, USA) transducer was placed at the level of the spine scapula in the transverse plane, and the upper medial border of the scapula, trapezius muscle, serratus posterior superior muscle (SPSM), 2nd and 3rd ribs were visualized. The ultrasound probe is rotated 90 degrees in a parasagittal orientation to identify the first rib. After its identification, the second and third ribs are confirmed. An 80 mm sono visible needle (type) was inserted in the caudocranial direction just medial to the scapula with the in-plane technique and driven between the 2nd and 3rd ribs targeting the inferior part of the SPSM. The target was confirmed by injecting the test dose with saline. Thirty ml of 0.25% bupivacaine was subsequently injected
erector spinae blockProcedure or surgery
US-guided ESPB, a commonly performed interfascial plane block, was first defined by Forero et al. (21). In this technique, LA is injected in the plane between the erector spinae muscles and the thoracic transverse processes. Thus, multiple thoracic levels are anesthetized by the LA spreading in a craniocaudal direction. The transducer was then placed approximately 3 cm lateral to the midline parasagittally. The T5 transverse process and the erector spinae, rhomboid major, trapezius muscles were viewed (i.e., from deep to superficial). The block needle was advanced in a craniocaudal direction using an in-plane approach through the trapezius, rhomboid major, and erector spinae muscles. After establishing contact with the hyperechoic transverse process, 30 mL of 0.25% bupivacaine was injected in small aliquots after hydrodissection (2-3 mL, 0.9% NaCl) and checking for negative blood aspiration after every 5 mL of injection.
| Study group | Role | What they receive |
|---|---|---|
| Group I (SP) | Active comparator | serratus posterior superior block Receives: Procedure: serratus posterior superior block |
| Group II (ES) | Active comparator | erector spinae block Receives: Procedure: erector spinae block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
The primary outcome is the total morphine consumption of the patient in the first 24 h postoperatively.
Measured: 24 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Mar 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast SurgeryStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Shabayek, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989372
- Sponsor's protocol ID
- FMASU R68/2025
- Status last verified
- Mar 2025
- First submitted
- 17 May 2025
- Last updated
- 25 May 2025
- Results posted
- 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 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Posterior Superior Intercostal Plane Block, Versus Erector Spinae Facial Plane Blocks A Comparative Study for Postoperative Pain Control and Opioid Consumption for Patient Undergoing Modified Radical Mastectomy Surgery
- ClinicalTrials.gov ID
- NCT06989372
- Acronym / sponsor ID
- FMASU R68/2025
- Conditions
- Breast Surgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 25 May 2025 (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.
Mastectomy is currently the most effective treatment for breast cancers in women. postoperative pain management carries a high degree of difficulty, as the breast has complex innervation involving the intercostal (T1-T7), superficial cervical plexus (supraclavicular nerves) and brachial plexus .While severe acute pain is observed in approximately 40% of post-mastectomy patients, moderate-to-severe pain is observed in almost one-third of them .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (SP) | Active comparator | Procedure: serratus posterior superior blockserratus posterior superior block |
| Group II (ES) | Active comparator | Procedure: erector spinae blockerector spinae block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 to 65 years
- ASA classification I and II
Key exclusion criteria (2 listed)
- age below 18 or above 65 years
- ASA classification III or more
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 |
|---|---|---|
| serratus posterior superior blockpatients were placed in the lateral decubitus position for SPSIPB. The blocks were performed under the guidance of ultrasonography (USG), a high-frequency linear probe (SonoSite HFL50x, 15-6 MHz, 55-mm broadband linear array, USA) transducer was placed at the level of the spine scapula in the transverse plane, and the upper medial border of the scapula, trapezius muscle, serratus posterior superior muscle (SPSM), 2nd and 3rd ribs were visualized. The ultrasound probe is rotated 90 degrees in a parasagittal orientation to identify the first rib. After its identification, the second and third ribs are confirmed. An 80 mm sono visible needle (type) was inserted in the caudocranial direction just medial to the scapula with the in-plane technique and driven between the 2nd and 3rd ribs targeting the inferior part of the SPSM. The target was confirmed by injecting the test dose with saline. Thirty ml of 0.25% bupivacaine was subsequently injected | Procedure or surgery | Group I (SP) |
| erector spinae blockUS-guided ESPB, a commonly performed interfascial plane block, was first defined by Forero et al. (21). In this technique, LA is injected in the plane between the erector spinae muscles and the thoracic transverse processes. Thus, multiple thoracic levels are anesthetized by the LA spreading in a craniocaudal direction. The transducer was then placed approximately 3 cm lateral to the midline parasagittally. The T5 transverse process and the erector spinae, rhomboid major, trapezius muscles were viewed (i.e., from deep to superficial). The block needle was advanced in a craniocaudal direction using an in-plane approach through the trapezius, rhomboid major, and erector spinae muscles. After establishing contact with the hyperechoic transverse process, 30 mL of 0.25% bupivacaine was injected in small aliquots after hydrodissection (2-3 mL, 0.9% NaCl) and checking for negative blood aspiration after every 5 mL of injection. | Procedure or surgery | Group II (ES) |
Primary outcome
Morphine consumption
Time frame: 24 hours post operatively
The primary outcome is the total morphine consumption of the patient in the first 24 h postoperatively.
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 25 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serratus posterior superior block and erector spinae block in people with Breast Surgery, run by Ain Shams 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 2 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: enrolling by invitation, as of the sponsor's last update on 25 May 2025. 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?
Morphine consumption (time frame: 24 hours post operatively). 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 May 2025.