AnalgesiaNCT04841564
Open Versus Ultrasound Approach for Serratus Anterior Block
A study testing ultrasound approach of serratus anterior block and open approach of serratus anterior block in people with Analgesia, run by Mansoura University at 1 site in Egypt.
Trial summary
Ultrasound-guided Serratus anterior plane (SAP) block is an interventional technique that recently gained popularity in the context of postoperative analgesia after breast surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- ultrasound approach of serratus anterior block and open approach of serratus anterior block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2021to 20 Jul 2024
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status scores of I and II
- Elective unilateral breast surgery (modified radical mastectomy)
Who cannot join
- Patient refusal to participate in the study.
- Allergy to any medications used in the study.
- Patients with coagulopathy
- patients with psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: An Open Approach Versus Ultrasound Approach for Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy: A Non-inferiority Study
Ultrasound-guided Serratus anterior plane (SAP) block is an interventional technique that recently gained popularity in the context of postoperative analgesia after breast surgery. Some limitations may be encountered during the use of ultrasound, such as obesity, tumor invasion of the surrounding muscles, which may lead to poor ultrasound image quality. The investigators hypothesized that an open approach to serratus anterior block by infiltration of local anesthetic between serratus anterior muscle and ribs after tumor excision during surgery would be non-inferior to ultrasound-guided approach where the primary endpoint of this prospective randomized blind controlled study will be the total dose of morphine consumed in the 1st postoperative 24 h. The patients will be randomly allocated to an open approach group and ultrasound approach group to serratus anterior block using computer-generated random numbers and sealed opaque envelops. For any statistical tests used results will be considered as statistically significant if P-value ≤0.05.
Read the detailed description
Modified radical mastectomy (MRM) is one of the most common surgeries performed, and one that may be associated with significant acute postoperative pain in breast surgery. Acute postoperative pain is an independent risk factor in the development of chronic post-mastectomy pain.
Various regional anesthetic procedures have been tried to provide better acute pain control and, consequently, less chronic pain. They can reduce perioperative opiates requirement and thereby decreasing their possible side effects. These regional procedures include local wound infiltration, thoracic epidural, and thoracic paravertebral block (PVB). pectoral nerves block type-1 (PECSI), pectoral nerves block type-2 (PECS II), and serratus plane block.
Ultrasound-guided Serratus anterior plane (SAP) block is an interventional technique that recently gained popularity in the context of breast surgery. SAP block resulted in better hemodynamic stability, early ambulation, and reduced duration of hospitalization as well as hospital costs in postoperative breast patients.
Some limitations may be encountered during the use of ultrasound, such as obesity, tumor invasion of the surrounding muscles, which may lead to poor ultrasound image quality. Also, ultrasound use depends on equipment quality and investigator experience.
The investigators hypothesized that an open approach to serratus anterior block by infiltration of local anesthetic between serratus anterior muscle and ribs after tumor excision during surgery would be non-inferior to ultrasound-guided approach in providing analgesia to female patients undergoing modified radical mastectomy. The primary endpoint will be the total dose of morphine consumed in the 1st postoperative 24 h. secondary outcomes will be the time of the first analgesic request (duration of the pain-free periods after surgery in the1st postoperative 24 hours), postoperative visual analog score (VAS), postoperative modified Ramsay sedation score, and PONV (post-operative nausea and vomiting).
- Conditions
- Analgesia
- Being tested
- ultrasound approach of serratus anterior block, open approach of serratus anterior block
- Keywords
- serratus anterior block, ultrasound, open, mastectomy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound approach of serratus anterior blockProcedure or surgery
Also called ultrasound approach
After induction of general anesthesia, the ultrasound probe will be placed longitudinally oblique just below the mid-clavicle. After identifying the second rib, the probe will be moved caudally and laterally (obliquely), towards the mid-axillary line to identify the 3rd, 4th and 5th ribs.. The fascial plane between the serratus anterior muscle and latissimus dorsi muscle will be identified over the 4th rib in the mid-axillary region. The block will be performed with a needle (22-G, 50-mm) introduced in-plane to enter deep to the serratus anterior muscle, and 30 ml 0.25 bupivacaine will be injected.
open approach of serratus anterior blockProcedure or surgery
Also called open approach
After resection of the breast and identification of the serratus anterior muscle, the surgeon will be asked to palpate the ribs below the clavicle and localize the fourth rib. A 22-G, 50-mm needle will be introduced deep to the serratus anterior muscle contacting the rib, and 30 ml 0.25 bupivacaine will be injected.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound group | Active comparator | serratus anterior plane block will be done through ultrasound guidance Receives: Procedure: ultrasound approach of serratus anterior block |
| Open group | Experimental | serratus anterior plane block will be done after mastectomy through the open wound Receives: Procedure: open approach of serratus anterior block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption given as a rescue analgesia
The amount of morphinel consumption in milligrams given as a rescue analgesia to patients when the vas score is more than 3
Measured: Up to 24 hours after the procedure
Secondary outcomes (6)
The period for the first analgesic required
duration of analgesia in minutes
Measured: Up to 24 hours after the procedure
Mean arterial blood pressure
Mean arterial blood pressure in mmHg will be recorded at baseline before surgical incision and postoperatively at 1, 4, 8, 12, 24 hours
Measured: Up to 24 hours after the procedure
visual analogue score (VAS) at rest
pain intensity will be assessed at rest with the 10 point visual analogue score (VAS) where 0 =no pain and 10 = the worst imaginable pain and the time points of measurements will be at 0, 1, 4, 8, 12 and 24 hours post-operatively.
Measured: Up to 24 hours after the procedure
postoperative complications
Any postoperative events like nausea, vomiting, respiratory depression( respiratory rate less than 12), urine retention, pruritis, local anesthetic toxicity and pneumothorax will be recorded.
Measured: Up to 24 hours after the procedure
Heart rate
Heart rate in beats per minute will be recorded at baseline before surgical incision and postoperatively at 1, 4, 8, 12, 24 hours
Measured: Up to 24 hours after the procedure
visual analogue score (VAS) at shoulder movement
pain intensity will be assessed at shoulder movement with the 10 point visual analogue score (VAS) where 0 =no pain and 10 = the worst imaginable pain and the time points of measurements will be at 0, 1, 4, 8, 12 and 24 hours post-operatively.
Measured: Up to 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start10 Apr 2021
- Primary completion15 Jun 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohammed Alseoudy, Mansoura University
- Investigators
- Mahmoud M Alseoudy, MD, Principal investigator, mansoura university, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841564
- Sponsor's protocol ID
- R.21.03.1262
- Status last verified
- Aug 2024
- First submitted
- 7 Apr 2021
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohammed ALseoudy M, Abd El-Ghaffar Saleh M, Saleh Elbalka S, Elmetwally Farahat T, Abdellatif Elebedy D, Elsayed Ahmed S. An open approach versus ultrasound approach for deep serratus anterior plane block for postoperative analgesia after modified radical mastectomy: A randomized controlled trial. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Nov;72(9):501902. doi: 10.1016/j.redare.2025.501902. Epub 2025 Sep 4.
PubMed 40914287
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Approach Versus Ultrasound Approach for Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy: A Non-inferiority Study
- ClinicalTrials.gov ID
- NCT04841564
- Acronym / sponsor ID
- R.21.03.1262
- Conditions
- Analgesia
- Keywords
- serratus anterior block, ultrasound, open, mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 12 Apr 2021 (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 Serratus anterior plane (SAP) block is an interventional technique that recently gained popularity in the context of postoperative analgesia after breast surgery. Some limitations may be encountered during the use of ultrasound, such as obesity, tumor invasion of the surrounding muscles, which may lead to poor ultrasound image quality. The investigators hypothesized that an open approach to serratus anterior block by infiltration of local anesthetic between serratus anterior muscle and ribs after tumor excision during surgery would be non-inferior to ultrasound-guided approach where the primary endpoint of this prospective randomized blind controlled study will be the total dose of morphine consumed in the 1st postoperative 24 h. The patients will be randomly allocated to an open approach group and ultrasound approach group to serratus anterior block using computer-generated random numbers and sealed opaque envelops. For any statistical tests used results will be considered as statistically significant if P-value ≤0.05.
Detailed description
Modified radical mastectomy (MRM) is one of the most common surgeries performed, and one that may be associated with significant acute postoperative pain in breast surgery. Acute postoperative pain is an independent risk factor in the development of chronic post-mastectomy pain.
Various regional anesthetic procedures have been tried to provide better acute pain control and, consequently, less chronic pain. They can reduce perioperative opiates requirement and thereby decreasing their possible side effects. These regional procedures include local wound infiltration, thoracic epidural, and thoracic paravertebral block (PVB). pectoral nerves block type-1 (PECSI), pectoral nerves block type-2 (PECS II), and serratus plane block.
Ultrasound-guided Serratus anterior plane (SAP) block is an interventional technique that recently gained popularity in the context of breast surgery. SAP block resulted in better hemodynamic stability, early ambulation, and reduced duration of hospitalization as well as hospital costs in postoperative breast patients.
Some limitations may be encountered during the use of ultrasound, such as obesity, tumor invasion of the surrounding muscles, which may lead to poor ultrasound image quality. Also, ultrasound use depends on equipment quality and investigator experience.
The investigators hypothesized that an open approach to serratus anterior block by infiltration of local anesthetic between serratus anterior muscle and ribs after tumor excision during surgery would be non-inferior to ultrasound-guided approach in providing analgesia to female patients undergoing modified radical mastectomy. The primary endpoint will be the total dose of morphine consumed in the 1st postoperative 24 h. secondary outcomes will be the time of the first analgesic request (duration of the pain-free periods after surgery in the1st postoperative 24 hours), postoperative visual analog score (VAS), postoperative modified Ramsay sedation score, and PONV (post-operative nausea and vomiting).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound group | Active comparator | Procedure: ultrasound approach of serratus anterior blockserratus anterior plane block will be done through ultrasound guidance |
| Open group | Experimental | Procedure: open approach of serratus anterior blockserratus anterior plane block will be done after mastectomy through the open wound |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status scores of I and II
- Elective unilateral breast surgery (modified radical mastectomy)
Key exclusion criteria (4 listed)
- Patient refusal to participate in the study.
- Allergy to any medications used in the study.
- Patients with coagulopathy
- patients with psychiatric disorders.
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 |
|---|---|---|
| ultrasound approach of serratus anterior blockAlso: ultrasound approachAfter induction of general anesthesia, the ultrasound probe will be placed longitudinally oblique just below the mid-clavicle. After identifying the second rib, the probe will be moved caudally and laterally (obliquely), towards the mid-axillary line to identify the 3rd, 4th and 5th ribs.. The fascial plane between the serratus anterior muscle and latissimus dorsi muscle will be identified over the 4th rib in the mid-axillary region. The block will be performed with a needle (22-G, 50-mm) introduced in-plane to enter deep to the serratus anterior muscle, and 30 ml 0.25 bupivacaine will be injected. | Procedure or surgery | ultrasound group |
| open approach of serratus anterior blockAlso: open approachAfter resection of the breast and identification of the serratus anterior muscle, the surgeon will be asked to palpate the ribs below the clavicle and localize the fourth rib. A 22-G, 50-mm needle will be introduced deep to the serratus anterior muscle contacting the rib, and 30 ml 0.25 bupivacaine will be injected. | Procedure or surgery | Open group |
Primary outcome
Morphine consumption given as a rescue analgesia
Time frame: Up to 24 hours after the procedure
The amount of morphinel consumption in milligrams given as a rescue analgesia to patients when the vas score is more than 3
6 secondary outcomes
The period for the first analgesic required
Time frame: Up to 24 hours after the procedure
Mean arterial blood pressure
Time frame: Up to 24 hours after the procedure
visual analogue score (VAS) at rest
Time frame: Up to 24 hours after the procedure
postoperative complications
Time frame: Up to 24 hours after the procedure
Heart rate
Time frame: Up to 24 hours after the procedure
visual analogue score (VAS) at shoulder movement
Time frame: Up to 24 hours after the procedure
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 27 Aug 2024.
- Derived from this study: PubMed 40914287Mohammed ALseoudy M, Abd El-Ghaffar Saleh M, Saleh Elbalka S, Elmetwally Farahat T, Abdellatif Elebedy D, Elsayed Ahmed S. An open approach versus ultrasound approach for deep serratus anterior plane block for postoperative analgesia after modified radical mastectomy: A randomized controlled trial. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Nov;72(9):501902. doi: 10.1016/j.redare.2025.501902. Epub 2025 Sep 4.
- 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.
Mahmoud M Alseoudy, MD principal investigator
mansoura university, faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound approach of serratus anterior block and open approach of serratus anterior block in people with Analgesia, run by Mansoura 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 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: finished, as of the sponsor's last update on 27 Aug 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?
Morphine consumption given as a rescue analgesia (time frame: Up to 24 hours after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04841564, which also lists 1 linked publication.
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 27 Aug 2024.