MastectomyNCT05224310
Comparing the Quality of Analgesia With Pectoral Nerve Block and Serratus Plane Block in Modified Radical Mastectomy
A study testing PECS block, SAP block in people with Mastectomy and Breast Cancer, run by Suez Canal University at 1 site in Egypt.
Trial summary
The use of pectoral nerve block (PECSB) is a new technique during modified radical mastectomy MRM. The Serratus anterior Plane (SAP) Block has been proven to be an effective component of multimodal analgesia regimens for a variety of thoracic procedures including MRM. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy, Breast Cancer
- What is being tested?
- PECS block, SAP 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
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Jul 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, female patients,
- ASA physical status I, II, and III
- Aged older than 18 years
- Scheduled for modified radical mastectomy surgery under general anaesthesia.
Who cannot join
- Any known allergies to the study drugs.
- Apparent anatomical abnormalities or infections in the serratus region.
- Bleeding disorders e.g. thrombocytopenia, high INR, high PT in the chronic liver or impaired kidney).
- Patients on chronic pain medications or regularly receiving analgesics.
- Pregnant or breastfeeding patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Quality of Analgesia With Ultrasound-guided Pectoral Nerve Block and Serratus Plane Block in Patients Undergoing Modified Radical Mastectomy
The use of pectoral nerve block (PECSB) is a new technique during modified radical mastectomy MRM.
The Serratus anterior Plane (SAP) Block has been proven to be an effective component of multimodal analgesia regimens for a variety of thoracic procedures including MRM.
In this study, the investigators will assess and compare the quality of analgesia with ultrasound-guided Serratus plane block and pectoral nerve block in patients undergoing modified radical mastectomy MRM.
Read the detailed description
Breast cancer is the most common cause of cancer death among women worldwide. In Egypt, breast cancer is the most common malignancy in women, accounting for 38.8% of cancers in this population. It is estimated that the breast cancer mortality rate is around 11%, being the second cause of cancer-related mortality after liver cancer.
According to the European network of cancer registries, most breast cancer patients require breast surgery to remove the primary tumour and axillary staging or dissection. Approximately 40% of these patients will experience clinically significant acute postoperative pain. Furthermore, acute postoperative pain is an important risk factor for the development of persistent chronic postoperative pain in women after breast surgery.
Acute postoperative pain is associated with increased comorbidity and hospital stay length; as it will affect respiratory functions, chest wall compliance, cardiac output, blood pressure, cardiac workload, metabolism, oxygen consumption, decreased tone of gastrointestinal and urinary tracts and marked increases in catabolic hormones (catecholamine, adrenocorticotrophic hormone, antidiuretic hormone, glucagon, and aldosterone) while decreasing anabolic hormones such as insulin and testosterone.
It has been reported that up to half of the patients have a negative impact of pain on their activities and up to one-quarter report moderate to high impact on their daily activities at home and work. Thus, more effective treatment modalities are used for decreasing postoperative pain in mastectomy patients include; patient-controlled analgesia PCA, thoracic epidural, and thoracic paravertebral block.
While the key requirement for successful regional anaesthetic blocks is ensuring optimal distribution of local anaesthetic around nerve structures, ultrasound guidance enables the anaesthetist to secure an accurate needle position and to monitor the distribution of the local anaesthetic in real-time.
It was found that blockade of the lateral cutaneous branches of thoracic intercostal nerves (T2-T12) will provide analgesia to the anterolateral chest wall in most patients.
The Serratus anterior Plane (SAP) Block has proven to be an effective component of multimodal analgesia regimens for a variety of thoracic procedures. It is designed to block primarily the thoracic intercostal nerves and to provide complete analgesia of the lateral part of the thorax and it may be a viable alternative to paravertebral blockade and thoracic epidural analgesia and may be associated with fewer side effects. It's straightforward to perform, with a high success rate and minimal incidence of complications. It was reported prolonged numbness over the area supplied by the lateral cutaneous branches of the T2-T9 spinal nerves using only 0.4 ml.kg-1 0.125% levobupivacaine. This is remarkable because alternative techniques such as intercostal, intrapleural and thoracic paravertebral block require relatively high concentrations and volumes of local anaesthetics to produce similarly prolonged, multi-dermatomal thoracic analgesia.
Blanco et al. reported the use of pectoral nerve block (PECSB) as a new technique during modified radical mastectomy MRM. PECSB is an interfascial plane block where local anaesthetics deposited into the plane between the pectoralis major muscle and the pectoralis minor muscle (PECS-I block) and above the serratus anterior muscle at the third rib (PECS-II block) blocking the pectoral, intercostobrachial, intercostals III, IV, V, and VI; and long thoracic nerves. The PECSB is expected to provide analgesia for breast cancer surgery BCS.
In this study, the investigators will assess and compare the quality of analgesia with ultrasound-guided Serratus plane block and pectoral nerve block in patients undergoing modified radical mastectomy.
- Conditions
- Mastectomy, Breast Cancer
- Being tested
- PECS block, SAP block
- Keywords
- analgesia, postoperative pain, PECS block, SAP block
- Medical subject headings
- Breast Neoplasms, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS block, SAP blockProcedure or surgery
performing either PECS block or SAP block
| Study group | Role | What they receive |
|---|---|---|
| Pectoral nerve block | Active comparator | Starting from the lateral third of the clavicle and moving distally and laterally to the midaxillary line. The pectoral major and minor muscles will be identified and 10 mL of bupivacaine 0.25% will be injected between the 2 muscles, and then move the ultrasound probe towards the axilla until the serratus anterior is identified above the second, third, and fourth ribs then injection of 20 mL of bupivacaine 0.25% after negative aspiration into the fascial plane between pectoralis minor and serratus anterior muscles. Receives: Procedure: PECS block, SAP block |
| Serratus anterior plane block | Active comparator | Aiming to find the serratus anterior muscle the investigator will identify the fifth rib in the midaxillary line by the linear probe in the sagittal plane. The latissimus dorsi muscle (superficial and posterior), teres major muscle (superior) and serratus muscles (deep and inferior) will be detected using ultrasound.
The investigator will penetrate the serratus anterior muscle by a 23 GA, 35 mm needle in-plane to ultrasound probe from supero-anterior to postero-inferior to inject deep to it. Receives: Procedure: PECS block, SAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first request for analgesia
the time from the completion of the block to the time of the first request for analgesia.
Measured: immediately at the end of 24 hours post operatively
Secondary outcomes (1)
Post-operative pain
pain will be evaluated using the "Visual Analogue Scale" at rest, the minimal score is 0 which means no pain at all, and the maximum is 10 which means unbearable pain, a higher score is worse and means a higher perception of pain, and more need for analgesia.
Measured: immediately postoperatively 0,2,4,6,8,12,14,16,18,20,22,and 24 h after surgery at rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Apr 2022
- Primary completion30 Jun 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
- Investigators
- Abdelrhman Alshawadfy, MD, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224310
- Sponsor's protocol ID
- PECS vs SAP
- Status last verified
- Aug 2022
- First submitted
- 24 Jan 2022
- Last updated
- 5 Aug 2022
- 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 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Quality of Analgesia With Ultrasound-guided Pectoral Nerve Block and Serratus Plane Block in Patients Undergoing Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT05224310
- Acronym / sponsor ID
- PECS vs SAP
- Conditions
- Mastectomy, Breast Cancer
- Keywords
- analgesia, postoperative pain, PECS block, SAP block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 4 Feb 2022 (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 use of pectoral nerve block (PECSB) is a new technique during modified radical mastectomy MRM.
The Serratus anterior Plane (SAP) Block has been proven to be an effective component of multimodal analgesia regimens for a variety of thoracic procedures including MRM.
In this study, the investigators will assess and compare the quality of analgesia with ultrasound-guided Serratus plane block and pectoral nerve block in patients undergoing modified radical mastectomy MRM.
Detailed description
Breast cancer is the most common cause of cancer death among women worldwide. In Egypt, breast cancer is the most common malignancy in women, accounting for 38.8% of cancers in this population. It is estimated that the breast cancer mortality rate is around 11%, being the second cause of cancer-related mortality after liver cancer.
According to the European network of cancer registries, most breast cancer patients require breast surgery to remove the primary tumour and axillary staging or dissection. Approximately 40% of these patients will experience clinically significant acute postoperative pain. Furthermore, acute postoperative pain is an important risk factor for the development of persistent chronic postoperative pain in women after breast surgery.
Acute postoperative pain is associated with increased comorbidity and hospital stay length; as it will affect respiratory functions, chest wall compliance, cardiac output, blood pressure, cardiac workload, metabolism, oxygen consumption, decreased tone of gastrointestinal and urinary tracts and marked increases in catabolic hormones (catecholamine, adrenocorticotrophic hormone, antidiuretic hormone, glucagon, and aldosterone) while decreasing anabolic hormones such as insulin and testosterone.
It has been reported that up to half of the patients have a negative impact of pain on their activities and up to one-quarter report moderate to high impact on their daily activities at home and work. Thus, more effective treatment modalities are used for decreasing postoperative pain in mastectomy patients include; patient-controlled analgesia PCA, thoracic epidural, and thoracic paravertebral block.
While the key requirement for successful regional anaesthetic blocks is ensuring optimal distribution of local anaesthetic around nerve structures, ultrasound guidance enables the anaesthetist to secure an accurate needle position and to monitor the distribution of the local anaesthetic in real-time.
It was found that blockade of the lateral cutaneous branches of thoracic intercostal nerves (T2-T12) will provide analgesia to the anterolateral chest wall in most patients.
The Serratus anterior Plane (SAP) Block has proven to be an effective component of multimodal analgesia regimens for a variety of thoracic procedures. It is designed to block primarily the thoracic intercostal nerves and to provide complete analgesia of the lateral part of the thorax and it may be a viable alternative to paravertebral blockade and thoracic epidural analgesia and may be associated with fewer side effects. It's straightforward to perform, with a high success rate and minimal incidence of complications. It was reported prolonged numbness over the area supplied by the lateral cutaneous branches of the T2-T9 spinal nerves using only 0.4 ml.kg-1 0.125% levobupivacaine. This is remarkable because alternative techniques such as intercostal, intrapleural and thoracic paravertebral block require relatively high concentrations and volumes of local anaesthetics to produce similarly prolonged, multi-dermatomal thoracic analgesia.
Blanco et al. reported the use of pectoral nerve block (PECSB) as a new technique during modified radical mastectomy MRM. PECSB is an interfascial plane block where local anaesthetics deposited into the plane between the pectoralis major muscle and the pectoralis minor muscle (PECS-I block) and above the serratus anterior muscle at the third rib (PECS-II block) blocking the pectoral, intercostobrachial, intercostals III, IV, V, and VI; and long thoracic nerves. The PECSB is expected to provide analgesia for breast cancer surgery BCS.
In this study, the investigators will assess and compare the quality of analgesia with ultrasound-guided Serratus plane block and pectoral nerve block in patients undergoing modified radical mastectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pectoral nerve block | Active comparator | Procedure: PECS block, SAP blockStarting from the lateral third of the clavicle and moving distally and laterally to the midaxillary line. The pectoral major and minor muscles will be identified and 10 mL of bupivacaine 0.25% will be injected between the 2 muscles, and then move the ultrasound probe towards the axilla until the serratus anterior is identified above the second, third, and fourth ribs then injection of 20 mL of bupivacaine 0.25% after negative aspiration into the fascial plane between pectoralis minor and serratus anterior muscles. |
| Serratus anterior plane block | Active comparator | Procedure: PECS block, SAP blockAiming to find the serratus anterior muscle the investigator will identify the fifth rib in the midaxillary line by the linear probe in the sagittal plane. The latissimus dorsi muscle (superficial and posterior), teres major muscle (superior) and serratus muscles (deep and inferior) will be detected using ultrasound. The investigator will penetrate the serratus anterior muscle by a 23 GA, 35 mm needle in-plane to ultrasound probe from supero-anterior to postero-inferior to inject deep to it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult, female patients,
- ASA physical status I, II, and III
- Aged older than 18 years
- Scheduled for modified radical mastectomy surgery under general anaesthesia.
Key exclusion criteria (5 listed)
- Any known allergies to the study drugs.
- Apparent anatomical abnormalities or infections in the serratus region.
- Bleeding disorders e.g. thrombocytopenia, high INR, high PT in the chronic liver or impaired kidney).
- Patients on chronic pain medications or regularly receiving analgesics.
- Pregnant or breastfeeding patients.
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 |
|---|---|---|
| PECS block, SAP blockperforming either PECS block or SAP block | Procedure or surgery | Pectoral nerve block, Serratus anterior plane block |
Primary outcome
The first request for analgesia
Time frame: immediately at the end of 24 hours post operatively
the time from the completion of the block to the time of the first request for analgesia.
1 secondary outcome
Post-operative pain
Time frame: immediately postoperatively 0,2,4,6,8,12,14,16,18,20,22,and 24 h after surgery at rest
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 5 Aug 2022.
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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.
Abdelrhman Alshawadfy, MD principal investigator
Suez Canal 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 PECS block, SAP block in people with Mastectomy and Breast Cancer, run by Suez Canal 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 4 inclusion and 5 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 5 Aug 2022. 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?
The first request for analgesia (time frame: immediately at the end of 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 5 Aug 2022.