AnesthesiaNCT06188156
Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II
A study testing Anethesia in people with Anesthesia and Radical Mastectomy, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Modified Radical Mastectomy accounts for 31% of all breast surgeries and considered the fundamental surgical management for breast cancer. Nearly 40-60% of patients experience severe acute postoperative pain. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Anesthesia, Radical Mastectomy
- What is being tested?
- Anethesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 28 Feb 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 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 35-65 years.
- BMI 18.5 - 25 kg/m2.
- American Society of Anesthesiologists (ASA) I-II.
Who cannot join
- Patient refusal.
- Coagulopathy.
- Mental and psychiatric disorders.
- History of chronic pain.
- Hypersensitivity or contraindication to any of study drugs
- Previous chemotherapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University hospitals
Cairo
Mohamed Abdelgawad, Assist.Prof, +201091945931, abosoad.mohamed2017@gmail.com
Mohamed Abdelgawad Aboelsuod, Assist.Prof.
About this study
Official title: Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II Compared to Thoracic Epidural Block After Unilateral Modified Radical Mastectomy
Modified Radical Mastectomy accounts for 31% of all breast surgeries and considered the fundamental surgical management for breast cancer. Nearly 40-60% of patients experience severe acute postoperative pain. This pain might persist for 6-12 months and result in post-mastectomy pain syndrome and complex regional pain syndrome (causalgia)
Read the detailed description
There are some local or regional nerve blocks in breast surgeries performed as core components of multimodal analgesia and enhanced recovery after surgery (ERAS), including thoracic epidural (TEB), interscalene brachial plexus, paravertebral, ultrasound-guided pectoral nerve block ( PECS II ), ultrasound-guided serratus anterior plane block (SAPB) and erector spinae plane block .
Thoracic epidural (TEB) is the gold standard technique following breast surgery, but there is still a problem with the adequacy of thoracic and axillary blockage during lymph node dissection .
Modified PECS's block" or PECS block type II aimed to block the axilla that is vital for axillary clearances and the intercostal nerves, necessary for wide excisions which can provide analgesia after breast surgery.
In the ultrasound-guided serratus anterior plane block (SAPB), the local anesthetic (LA) is injected in the compartment between the serratus anterior and latissimus dorsi muscles. SAPB anesthetizes the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve thus providing analgesia for breast and lateral thoracic wall surgeries
- Conditions
- Anesthesia, Radical Mastectomy
- Being tested
- Anethesia
- Keywords
- thoracic epidural blockage, Ultrasound Guided Serratus Anterior Plane Block, Pectoral Nerve Block II, Radical Mastectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnethesiaProcedure or surgery
To assess the effectiveness of thoracic epidural blockage versus ultrasonic guided PECS II block versus ultrasound guided serratus anterior plane block for postoperative pain management in modified radical mastectomy.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Epidural Block(Group 1) | Active comparator | About 33 Patients will receive thoracic epidural block with an injection of a single shot of 15ml of 0.25% bupivacaine between T4 and T5 vertebrae. Receives: Procedure: Anethesia |
| Ultrasound Guided Sserratus Anterior Plane Block (Group 2) | Active comparator | About 33 Patients will receive Ultrasound Guided Sserratus Anterior Plane Block( SAPB) with an injection of 30 ml bupivacaine 0.25% . Receives: Procedure: Anethesia |
| Ultrasound Guided Pectoral Nerve Block (Group 3) | Active comparator | About 33 Patients will receive Ultrasound Guided Pectoral Nerve Block ( PECS II) with an injection of 20 ml bupivacaine 0.25% of pectoral-minor above the Serratus anterior muscle. Receives: Procedure: Anethesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Post-operative Pain
Assessment of the pain post-operatively in patients with pain assessed by VAS score : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain
Measured: First 24-hour analgesic after Mastectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Feb 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed A Aboelsuod, MD, Al-Azhar University
- Investigators
- Alaa Aldine Mahmoud Said, Professor, Study chair, Al-Azhar University, Faculty of medicine for boys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188156
- Sponsor's protocol ID
- Ahmed Elbasuni Ali
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II Compared to Thoracic Epidural Block After Unilateral Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT06188156
- Acronym / sponsor ID
- Ahmed Elbasuni Ali
- Conditions
- Anesthesia, Radical Mastectomy
- Keywords
- thoracic epidural blockage, Ultrasound Guided Serratus Anterior Plane Block, Pectoral Nerve Block II, Radical Mastectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 3 Jan 2024 (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.
Modified Radical Mastectomy accounts for 31% of all breast surgeries and considered the fundamental surgical management for breast cancer. Nearly 40-60% of patients experience severe acute postoperative pain. This pain might persist for 6-12 months and result in post-mastectomy pain syndrome and complex regional pain syndrome (causalgia)
Detailed description
There are some local or regional nerve blocks in breast surgeries performed as core components of multimodal analgesia and enhanced recovery after surgery (ERAS), including thoracic epidural (TEB), interscalene brachial plexus, paravertebral, ultrasound-guided pectoral nerve block ( PECS II ), ultrasound-guided serratus anterior plane block (SAPB) and erector spinae plane block .
Thoracic epidural (TEB) is the gold standard technique following breast surgery, but there is still a problem with the adequacy of thoracic and axillary blockage during lymph node dissection .
Modified PECS's block" or PECS block type II aimed to block the axilla that is vital for axillary clearances and the intercostal nerves, necessary for wide excisions which can provide analgesia after breast surgery.
In the ultrasound-guided serratus anterior plane block (SAPB), the local anesthetic (LA) is injected in the compartment between the serratus anterior and latissimus dorsi muscles. SAPB anesthetizes the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve thus providing analgesia for breast and lateral thoracic wall surgeries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thoracic Epidural Block(Group 1) | Active comparator | Procedure: AnethesiaAbout 33 Patients will receive thoracic epidural block with an injection of a single shot of 15ml of 0.25% bupivacaine between T4 and T5 vertebrae. |
| Ultrasound Guided Sserratus Anterior Plane Block (Group 2) | Active comparator | Procedure: AnethesiaAbout 33 Patients will receive Ultrasound Guided Sserratus Anterior Plane Block( SAPB) with an injection of 30 ml bupivacaine 0.25% . |
| Ultrasound Guided Pectoral Nerve Block (Group 3) | Active comparator | Procedure: AnethesiaAbout 33 Patients will receive Ultrasound Guided Pectoral Nerve Block ( PECS II) with an injection of 20 ml bupivacaine 0.25% of pectoral-minor above the Serratus anterior muscle. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 35-65 years.
- BMI 18.5 - 25 kg/m2.
- American Society of Anesthesiologists (ASA) I-II.
Key exclusion criteria (6 listed)
- Patient refusal.
- Coagulopathy.
- Mental and psychiatric disorders.
- History of chronic pain.
- Hypersensitivity or contraindication to any of study drugs
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 |
|---|---|---|
| AnethesiaTo assess the effectiveness of thoracic epidural blockage versus ultrasonic guided PECS II block versus ultrasound guided serratus anterior plane block for postoperative pain management in modified radical mastectomy. | Procedure or surgery | Thoracic Epidural Block(Group 1), Ultrasound Guided Pectoral Nerve Block (Group 3), Ultrasound Guided Sserratus Anterior Plane Block (Group 2) |
Primary outcome
Measurement of Post-operative Pain
Time frame: First 24-hour analgesic after Mastectomy
Assessment of the pain post-operatively in patients with pain assessed by VAS score : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 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.
Alaa Aldine Mahmoud Said, Professor study chair
Al-Azhar University, Faculty of medicine for boys
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anethesia in people with Anesthesia and Radical Mastectomy, run by Al-Azhar 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: status not confirmed, as of the sponsor's last update on 3 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Elbasuni, MSC (+201125373436, ahmedelbasuni86@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Post-operative Pain (time frame: First 24-hour analgesic after Mastectomy). 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 3 Jan 2024.