Breast CancerNCT04895397
Modified Pectoral Nerve Block Versus Serratus Plane Block
A study testing ultrasound guided Nerve Block procedure in people with Breast Cancer, run by Sohag University.
Trial summary
In PECSII or modified PECSI block, local anesthetic (LA) is injected between pectoralis major muscle (PMm) and pectoralis minor muscle (Pmm) to block lateral and medial pectoral nerves and between pectoralis minor muscle (Pmm) and serratus anterior muscle in the anterior axillary line to block the intercostal nerves… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ultrasound guided Nerve Block procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2021to 20 Aug 2023
- 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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Breast cancer surgery.
- Age 20 to 60 years.
- Female patients.
- At least 24 hours post-operative hospital admission.
- ASA (American society of anesthesiologist) physical status classification system І to Ш.
Who cannot join
- • Morbid obesity (body mass index > 40).
- Impossibility of anatomical structures identification by ultrasound in a satisfactory way (there can be no distinction in the interfacial plan between serratus and pectoral muscle).
- Opioids treatment before surgery or substance abuse.
- Sepsis and/or infection at the puncture site.
- Hemostasis disorders.
- Allergy to any of the drugs used in the study.
- Less than 24 hours postoperative hospital admission.
- Inability to communicate with the patient.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Modified Pectoral Nerve Block Versus Serratus Plane Block for Analgesia After Breast Cancer Surgeries
In PECSII or modified PECSI block, local anesthetic (LA) is injected between pectoralis major muscle (PMm) and pectoralis minor muscle (Pmm) to block lateral and medial pectoral nerves and between pectoralis minor muscle (Pmm) and serratus anterior muscle in the anterior axillary line to block the intercostal nerves II-VI (Blanco et al., 2012).
In Serratus anterior plane block (SAPB) local anesthetic (LA) is injected above the serratus muscle (between latissmus dorsi muscle and serratus muscle) or below the serratus muscle (between serratus muscle and 4th rib) in the mid-axillary line to block the intercostal nerves II-VI and spares the pectoral nerves (Blanco et al., 2013).
Read the detailed description
One hour before induction of anesthesia 4ml blood sample will be taken from all patient to measure serum cortisol and serum endorphin level 2ml for each.
General anesthesia will be induced for all patients in both groups using the same protocol.
Anesthesia will be induced with propfol (2-3 mg/kg), IV rocuroniom (.5 - .8 mg/kg) to facilitate endotracheal intubation. Anesthesia will be maintained with isoflurane (1-2 mac) in 100% oxygen.
All patients will be intubated and mechanically ventilated using volume controlled positive pressure ventilation with a tidal volume of 6-8 ml/kg and an inspiratory to expiratory ratio of 1:2 targeting end tidal carbon dioxide tension around 35mmhg.
Basic monitoring for all patients include under pulse oximetry, non-invasive blood pressure, 5 lead electrocardiogram and end tidal carbon dioxide monitoring.
In group A patients, an ultrasound guided modified pectoral nerve block will be performed after induction of general anesthesia. Under sterile conditions, US-guided PECSII block will be on the same side of surgery with the patient lying in the supine position with the ipsilateral arm abducted and externally rotated, and the elbow flexed 90°. The 6-13 MHz linear probe will be put transversely in the ipsilateral clavipectoral triangle - between the clavicle medially and above and the shoulder joint laterally.
After identification of the Pectoralis major muscle, Pectoralis minor muscle and the plane in between, the probe will be tilted caudally to identify the pulsating pectoral branch of the thoracoacromial artery, if not identified, the probe will be moved 1-2 cm caudally and medially. In a caudal tilt, the artery will be easily identified in a biconvex space.
The skin at the point of entry was infiltrated using lidocaine 1%; then, the needle (disposable spinal needle, K-3 point type LUER-Lock HUB 22G) will be advanced in an in-plane technique targeting the space in which the artery is located. Two mL of saline 0.9% will be injected to confirm the location, produce hydro-dissection, and improve needle visualization. Afterward, 10 mL of bupivacaine, 0.25%, will be injected.
Then, the probe will be moved laterally and caudally towards the anterior axillary fold, parallel to the deltopectoral groove, until the serratus muscle appears underneath the Pectoralis minor muscle attached to the underlying ribs.
The 3rd, fourth ribs and the pleura will be then identified. After infiltration of the skin with lidocaine 1%, the needle will be advanced in-plane targeting the plane between the pectoralis minor muscle and serratus. Two mL of saline 0.9% will be injected; then, 10 mL of bupivacaine 0.25% will be injected.
Group B: In SAPB Group, a US-guided serratus block will be done with the patient in the lateral position, with the side of the surgical side up and the upper limb hanging over the patient's head. The ribs will be then counted, and when the 4th rib will be identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane.
The ribs, pleura, and overlying serratus muscle will be identified, and the needle will be advanced cephalad in-plane until the tip touched the 4th rib. Afterward, 2 mL saline 0.9% will be injected; then, 20 mL of bupivacaine 0.25% will be injected in the plane between the serratus and the 4th rib.
At the end of the surgery, the muscle relaxant will be reversed using neostigmine (0.04 mg/kg) and atropine (0.01 mg/kg). After fully awake extubation, all patients will be transferred to the post-anesthesia care unit (PACU).
Two hour post-operative 4ml blood sample will be taken from all patients to measure serum cortisol and serum endorphin level 2ml for each.
- Conditions
- Breast Cancer
- Being tested
- ultrasound guided Nerve Block procedure
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided Nerve Block procedureDevice
In group A patients, an ultrasound guided modified pectoral nerve block will be performed Under sterile conditions, US-guided PECSII block will be on the same side of surgery . The 6-13 MHz linear probe will be put transversely in the ipsilateral clavipectoral triangle - between the clavicle medially and above and the shoulder joint laterally.
the needle will be advanced in an in-plane technique targeting the space in which the artery is located. Afterward, 10 mL of bupivacaine, 0.25%, will be injected.
the needle will be advanced in-plane targeting the plane between the pectoralis minor muscle and serratus. Two mL of saline 0.9% will be injected; then, 10 mL of bupivacaine 0.25% will be injected.
Group B: In SAPB Group, a US-guided serratus block will be done The ribs will be then counted, and when the 4th rib will be identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane.
| Study group | Role | What they receive |
|---|---|---|
| Group A: (30 patients) | Active comparator | modified pectoral nerve block will be done. Receives: Device: ultrasound guided Nerve Block procedure |
| Group B: (30 patients) | Active comparator | serratus plane block will be done. Receives: Device: ultrasound guided Nerve Block procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess analgesic effect of nerve block
We assess the analgesic effect by VAS ( visual analogue scale )
Measured: 24hour post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start20 May 2021 (estimated)
- Primary completion20 Jun 2023 (estimated)
- Study completion20 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: (30 patients) modified pectoral nerve block will be done. Group B: (30 patients) serratus plane block will be done.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hussin Mohamed, Sohag University
- Investigators
- mohammed hussein, lecturer, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895397
- Sponsor's protocol ID
- soh-Med-21-02-05
- Status last verified
- May 2021
- First submitted
- 24 Apr 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- 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 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Pectoral Nerve Block Versus Serratus Plane Block for Analgesia After Breast Cancer Surgeries
- ClinicalTrials.gov ID
- NCT04895397
- Acronym / sponsor ID
- soh-Med-21-02-05
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 May 2021 (estimated)
- Primary completion
- 20 Jun 2023 (estimated)
- Study completion
- 20 Aug 2023 (estimated)
- First posted
- 20 May 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.
In PECSII or modified PECSI block, local anesthetic (LA) is injected between pectoralis major muscle (PMm) and pectoralis minor muscle (Pmm) to block lateral and medial pectoral nerves and between pectoralis minor muscle (Pmm) and serratus anterior muscle in the anterior axillary line to block the intercostal nerves II-VI (Blanco et al., 2012).
In Serratus anterior plane block (SAPB) local anesthetic (LA) is injected above the serratus muscle (between latissmus dorsi muscle and serratus muscle) or below the serratus muscle (between serratus muscle and 4th rib) in the mid-axillary line to block the intercostal nerves II-VI and spares the pectoral nerves (Blanco et al., 2013).
Detailed description
One hour before induction of anesthesia 4ml blood sample will be taken from all patient to measure serum cortisol and serum endorphin level 2ml for each.
General anesthesia will be induced for all patients in both groups using the same protocol.
Anesthesia will be induced with propfol (2-3 mg/kg), IV rocuroniom (.5 - .8 mg/kg) to facilitate endotracheal intubation. Anesthesia will be maintained with isoflurane (1-2 mac) in 100% oxygen.
All patients will be intubated and mechanically ventilated using volume controlled positive pressure ventilation with a tidal volume of 6-8 ml/kg and an inspiratory to expiratory ratio of 1:2 targeting end tidal carbon dioxide tension around 35mmhg.
Basic monitoring for all patients include under pulse oximetry, non-invasive blood pressure, 5 lead electrocardiogram and end tidal carbon dioxide monitoring.
In group A patients, an ultrasound guided modified pectoral nerve block will be performed after induction of general anesthesia. Under sterile conditions, US-guided PECSII block will be on the same side of surgery with the patient lying in the supine position with the ipsilateral arm abducted and externally rotated, and the elbow flexed 90°. The 6-13 MHz linear probe will be put transversely in the ipsilateral clavipectoral triangle - between the clavicle medially and above and the shoulder joint laterally.
After identification of the Pectoralis major muscle, Pectoralis minor muscle and the plane in between, the probe will be tilted caudally to identify the pulsating pectoral branch of the thoracoacromial artery, if not identified, the probe will be moved 1-2 cm caudally and medially. In a caudal tilt, the artery will be easily identified in a biconvex space.
The skin at the point of entry was infiltrated using lidocaine 1%; then, the needle (disposable spinal needle, K-3 point type LUER-Lock HUB 22G) will be advanced in an in-plane technique targeting the space in which the artery is located. Two mL of saline 0.9% will be injected to confirm the location, produce hydro-dissection, and improve needle visualization. Afterward, 10 mL of bupivacaine, 0.25%, will be injected.
Then, the probe will be moved laterally and caudally towards the anterior axillary fold, parallel to the deltopectoral groove, until the serratus muscle appears underneath the Pectoralis minor muscle attached to the underlying ribs.
The 3rd, fourth ribs and the pleura will be then identified. After infiltration of the skin with lidocaine 1%, the needle will be advanced in-plane targeting the plane between the pectoralis minor muscle and serratus. Two mL of saline 0.9% will be injected; then, 10 mL of bupivacaine 0.25% will be injected.
Group B: In SAPB Group, a US-guided serratus block will be done with the patient in the lateral position, with the side of the surgical side up and the upper limb hanging over the patient's head. The ribs will be then counted, and when the 4th rib will be identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane.
The ribs, pleura, and overlying serratus muscle will be identified, and the needle will be advanced cephalad in-plane until the tip touched the 4th rib. Afterward, 2 mL saline 0.9% will be injected; then, 20 mL of bupivacaine 0.25% will be injected in the plane between the serratus and the 4th rib.
At the end of the surgery, the muscle relaxant will be reversed using neostigmine (0.04 mg/kg) and atropine (0.01 mg/kg). After fully awake extubation, all patients will be transferred to the post-anesthesia care unit (PACU).
Two hour post-operative 4ml blood sample will be taken from all patients to measure serum cortisol and serum endorphin level 2ml for each.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Group A: (30 patients) modified pectoral nerve block will be done. Group B: (30 patients) serratus plane block will be done.
| Arm | Type | Receives |
|---|---|---|
| Group A: (30 patients) | Active comparator | Device: ultrasound guided Nerve Block proceduremodified pectoral nerve block will be done. |
| Group B: (30 patients) | Active comparator | Device: ultrasound guided Nerve Block procedureserratus plane block will be done. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Breast cancer surgery.
- Age 20 to 60 years.
- Female patients.
- At least 24 hours post-operative hospital admission.
- ASA (American society of anesthesiologist) physical status classification system І to Ш.
Key exclusion criteria (8 listed)
- • Morbid obesity (body mass index > 40).
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 guided Nerve Block procedureIn group A patients, an ultrasound guided modified pectoral nerve block will be performed Under sterile conditions, US-guided PECSII block will be on the same side of surgery . The 6-13 MHz linear probe will be put transversely in the ipsilateral clavipectoral triangle - between the clavicle medially and above and the shoulder joint laterally. the needle will be advanced in an in-plane technique targeting the space in which the artery is located. Afterward, 10 mL of bupivacaine, 0.25%, will be injected. the needle will be advanced in-plane targeting the plane between the pectoralis minor muscle and serratus. Two mL of saline 0.9% will be injected; then, 10 mL of bupivacaine 0.25% will be injected. Group B: In SAPB Group, a US-guided serratus block will be done The ribs will be then counted, and when the 4th rib will be identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane. | Device | Group A: (30 patients), Group B: (30 patients) |
Primary outcome
assess analgesic effect of nerve block
Time frame: 24hour post-operative
We assess the analgesic effect by VAS ( visual analogue scale )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- 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.
mohammed hussein, lecturer principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided Nerve Block procedure in people with Breast Cancer, run by Sohag University.
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 5 inclusion and 8 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 20 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohammed hussein, lecturer (01005872429, mohamedhussin@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess analgesic effect of nerve block (time frame: 24hour post-operative). 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 20 May 2021.