Breast CancerNCT07650305
Bilevel Erector Spinae Plane Block Versus Pectoserratus Block for Analgesia in Modified Radical Mastectomy
A study testing Ultrasound guided bilevel Erector spinae plane block (ESPB) and Ultrasound guided Pectoserratus Block in people with Breast Cancer, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Breast cancer remains the most frequently diagnosed cancer and a major cause of cancer-related mortality among women worldwide. Modified radical mastectomy (MRM), a common surgical procedure for breast cancer, is associated with significant postoperative pain, which may delay recovery and contribute to the development… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultrasound guided bilevel Erector spinae plane block (ESPB) and Ultrasound guided Pectoserratus Block
- Type of treatment
- 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 May 2026to 2 Aug 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer female patients.
- ASA class II and III.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
- Type of surgery; elective breast cancer surgery modified radical mastectomy combined with axillary dissection.
Who cannot join
- Patient refusal.
- Age <18 years or >65 years.
- BMI <20 kg/m2 and >35 kg/m2.
- Major medical conditions.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute - Cairo University
Cairo, 11796
Ayman Sharawy AbdelRahman Aboul Nasr, MD, +201282649008 ext. 0020, ayman.sharawy@nci.cu.edu.eg
Yousr Farag Abdelhamid, MSc, 01095444856, dr.yousrfarag@gmail.com
About this study
Official title: Bilevel Erector Spinae Plane Block Versus Pecto-serratus Block for Analgesia in Modified Radical Mastectomy in Cancer Surgery
Breast cancer remains the most frequently diagnosed cancer and a major cause of cancer-related mortality among women worldwide. Modified radical mastectomy (MRM), a common surgical procedure for breast cancer, is associated with significant postoperative pain, which may delay recovery and contribute to the development of chronic postmastectomy pain syndrome (PMPS). To address this, regional anesthesia techniques have been increasingly incorporated into multimodal analgesia strategies to reduce opioid consumption and enhance patient outcomes. Interfascial plane blocks, in particular, offer safe and effective analgesia under ultrasound guidance. The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery
Read the detailed description
Breast cancer is the most common diagnosed malignancy among females and the 5th cause of cancer-related deaths with an estimated number of 2.3 million new cases and 685,000 deaths worldwide in 2020.
Different modalities are used for management of breast cancer including surgery, radiation therapy (RT), chemotherapy (CT), endocrine (hormone) therapy (ET), and targeted therapy. Modified Radical Mastectomy (MRM) is one of the main modalities of breast cancer treatment. It accounts for 31% of all breast surgeries. It has been reported that 40% of the females complain from moderate-to-severe pain in the immediate post-operative period after breast cancer surgery.
Acute post-mastectomy pain can cause adverse impacts on the patients as delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic post mastectomy pain syndrome (PMPS) in almost half of the patients.
Various regional anesthetic techniques have been described for postoperative pain relief after mastectomy, for example, thoracic epidural anesthesia, intercostal nerve block, paravertebral block, serratus anterior plane block, and pectoral nerve I and II blocks. All of them offer satisfactory pain relief after mastectomy.
The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery
- Conditions
- Breast Cancer
- Being tested
- Ultrasound guided bilevel Erector spinae plane block (ESPB), Ultrasound guided Pectoserratus Block
- Keywords
- erector spinae plane block, pectoserratus block, ultrasound
- 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 bilevel Erector spinae plane block (ESPB)Procedure or surgery
Ultrasound guided bilevel Erector spinae plane block
Ultrasound guided Pectoserratus BlockProcedure or surgery
ultra sound guided combined Pectoral Nerve (PECS II) Block and Serratus anterior (SAPB) plane block
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided bilevel Erector spinae plane block (ESPB) | Active comparator | Before induction of general anesthesia, patients will be positioned in the sitting position leaning forward. The 3rd and 5th vertebral spinous processes will be first identified then the block area will be adequately sterilized and draped. The block will be done as needed using either a high frequency linear probe (6- 13 MHz) or a curved (2-5 MHz) probe of . The probe used to identify the hyperechoic transverse process shadow at approximately 1.5- 2 cm distance from the spinous process deep to the trapezius, rhomboid major, and erector spinae muscles at 3rd, 5th vertebrae. Then, an 18-gauge epidural needle will be inserted in a cephalad-to-caudad direction to reach the transverse process deep to the erector spinae muscle. Correct positioning of the needle will be confirmed through real time visualization of 2 ml saline hydro dissection at both 3rd and 5th vertebrae.20 ml of bupivacaine 0.25% will be injected at each level. Receives: Procedure: Ultrasound guided bilevel Erector spinae plane block (ESPB) |
| Ultrasound guided Pectoserratus Block (PSPB) | Active comparator | For the PECS block, the patient's arm is abducted 90° and externally rotated. The ultrasound probe is positioned beneath the lateral third of the clavicle to locate the axillary vessels and subclavian artery. The probe is moved distally and laterally to the second and third rib space to identify the pectoralis major. A 20G, 100 mm echogenic needle is inserted between the pectoralis muscles; 15 mL of local anesthetic (LA) is administered in 5 cc increments. The probe is then shifted distally and laterally to the third and fourth rib space. The fascial plane between the pectoralis minor and serratus anterior muscles is identified , and 10 mL of LA is injected in 5 cc increments. For the SAPB, the probe is placed on the midaxillary line at the fifth rib level to visualize the serratus anterior and latissimus dorsi. A 22G spinal needle is inserted in-plane at a 45° angle toward the fifth rib. Saline (0.5-1 mL) is injected to open the plane, and 15 mL of 0.25% LA is administered Receives: Procedure: Ultrasound guided Pectoserratus Block |
| control group | No intervention | the patients of this group received general anesthesia without regional plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total post-operative morphine consumption.
The total 24-hour morphine consumption will be recorded for every patient post operative.
Measured: 24 hours after the surgery
Secondary outcomes (5)
Total intra-operative fentanyl consumption
the rescue analgesia will be administered intra-operative by fentanyl IV and the total fentanyl used will be recorded and compared between the groups
Measured: 2-3 hours (Surgery time) surgery
1st time opioids requested post-operative.
In case of postoperative pain recorded, rescue analgesia will be provided as IV morphine (3 mg) then continuous infusion of morphine through Patient Controlled Analgesia ( PCA ) to keep the VAS scores<3. The total 24-hour morphine consumption will be recorded for every patient.
Measured: 24 hours after the surgery
Changes and stability in Mean Arterial Blood Pressure (MAP)
Change in Mean Arterial Blood Pressure (MAP) in mmHg
Measured: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
Changes and stability in Heart Rate (HR)
Change in heart rate (HR) in beat\min
Measured: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
Pain scores using Visual analogue score
Pain scores using Visual analogue score (VAS) (0 mm = no pain to 10mm = worst pain imaginable) at predetermined time intervals (1, 2, 6, 12 and 24h) postoperative.
Measured: 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 May 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion2 Aug 2026 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Sharawy Abdel Rahman Aboul Nasr, National Cancer Institute, Egypt
- Investigators
- Ayman Sharawy Abdelrahman Aboul Nasr, MD, Study director, National Cancer Institute Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650305
- Sponsor's protocol ID
- AP2601-201-221-206
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilevel Erector Spinae Plane Block Versus Pecto-serratus Block for Analgesia in Modified Radical Mastectomy in Cancer Surgery
- ClinicalTrials.gov ID
- NCT07650305
- Acronym / sponsor ID
- AP2601-201-221-206
- Conditions
- Breast Cancer
- Keywords
- erector spinae plane block, pectoserratus block, ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 2 Aug 2026 (estimated)
- First posted
- 16 Jun 2026 (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.
Breast cancer remains the most frequently diagnosed cancer and a major cause of cancer-related mortality among women worldwide. Modified radical mastectomy (MRM), a common surgical procedure for breast cancer, is associated with significant postoperative pain, which may delay recovery and contribute to the development of chronic postmastectomy pain syndrome (PMPS). To address this, regional anesthesia techniques have been increasingly incorporated into multimodal analgesia strategies to reduce opioid consumption and enhance patient outcomes. Interfascial plane blocks, in particular, offer safe and effective analgesia under ultrasound guidance. The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery
Detailed description
Breast cancer is the most common diagnosed malignancy among females and the 5th cause of cancer-related deaths with an estimated number of 2.3 million new cases and 685,000 deaths worldwide in 2020.
Different modalities are used for management of breast cancer including surgery, radiation therapy (RT), chemotherapy (CT), endocrine (hormone) therapy (ET), and targeted therapy. Modified Radical Mastectomy (MRM) is one of the main modalities of breast cancer treatment. It accounts for 31% of all breast surgeries. It has been reported that 40% of the females complain from moderate-to-severe pain in the immediate post-operative period after breast cancer surgery.
Acute post-mastectomy pain can cause adverse impacts on the patients as delayed discharge from post-operative recovery area, impairs pulmonary and immune functions, increases risk of ileus, thromboembolism, myocardial infarction and may lead to increased length of hospital stay. It is also an important factor leading to the development of chronic post mastectomy pain syndrome (PMPS) in almost half of the patients.
Various regional anesthetic techniques have been described for postoperative pain relief after mastectomy, for example, thoracic epidural anesthesia, intercostal nerve block, paravertebral block, serratus anterior plane block, and pectoral nerve I and II blocks. All of them offer satisfactory pain relief after mastectomy.
The erector spinae plane block (ESPB), first described in 2016, involves injection of local anesthetic deep to the erector spinae muscle and may spread to the paravertebral space, providing both somatic and visceral analgesia. A bilevel approach may enhance dermatomal coverage. Meanwhile, the pectoserratus plane block (PSPB), which combines PECS II and serratus anterior blocks, targets nerves of the anterior and lateral chest wall and has shown efficacy in breast surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided bilevel Erector spinae plane block (ESPB) | Active comparator | Procedure: Ultrasound guided bilevel Erector spinae plane block (ESPB)Before induction of general anesthesia, patients will be positioned in the sitting position leaning forward. The 3rd and 5th vertebral spinous processes will be first identified then the block area will be adequately sterilized and draped. The block will be done as needed using either a high frequency linear probe (6- 13 MHz) or a curved (2-5 MHz) probe of . The probe used to identify the hyperechoic transverse process shadow at approximately 1.5- 2 cm distance from the spinous process deep to the trapezius, rhomboid major, and erector spinae muscles at 3rd, 5th vertebrae. Then, an 18-gauge epidural needle will be inserted in a cephalad-to-caudad direction to reach the transverse process deep to the erector spinae muscle. Correct positioning of the needle will be confirmed through real time visualization of 2 ml saline hydro dissection at both 3rd and 5th vertebrae.20 ml of bupivacaine 0.25% will be injected at each level. |
| Ultrasound guided Pectoserratus Block (PSPB) | Active comparator | Procedure: Ultrasound guided Pectoserratus BlockFor the PECS block, the patient's arm is abducted 90° and externally rotated. The ultrasound probe is positioned beneath the lateral third of the clavicle to locate the axillary vessels and subclavian artery. The probe is moved distally and laterally to the second and third rib space to identify the pectoralis major. A 20G, 100 mm echogenic needle is inserted between the pectoralis muscles; 15 mL of local anesthetic (LA) is administered in 5 cc increments. The probe is then shifted distally and laterally to the third and fourth rib space. The fascial plane between the pectoralis minor and serratus anterior muscles is identified , and 10 mL of LA is injected in 5 cc increments. For the SAPB, the probe is placed on the midaxillary line at the fifth rib level to visualize the serratus anterior and latissimus dorsi. A 22G spinal needle is inserted in-plane at a 45° angle toward the fifth rib. Saline (0.5-1 mL) is injected to open the plane, and 15 mL of 0.25% LA is administered |
| control group | No intervention | –the patients of this group received general anesthesia without regional plane block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Breast cancer female patients.
- ASA class II and III.
- Age ≥ 18 and ≤ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
- Type of surgery; elective breast cancer surgery modified radical mastectomy combined with axillary dissection.
Key exclusion criteria (5 listed)
- Patient refusal.
- Age <18 years or >65 years.
- BMI <20 kg/m2 and >35 kg/m2.
- Major medical conditions.
- Pregnancy or lactation.
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 bilevel Erector spinae plane block (ESPB)Ultrasound guided bilevel Erector spinae plane block | Procedure or surgery | Ultrasound guided bilevel Erector spinae plane block (ESPB) |
| Ultrasound guided Pectoserratus Blockultra sound guided combined Pectoral Nerve (PECS II) Block and Serratus anterior (SAPB) plane block | Procedure or surgery | Ultrasound guided Pectoserratus Block (PSPB) |
Primary outcome
Total post-operative morphine consumption.
Time frame: 24 hours after the surgery
The total 24-hour morphine consumption will be recorded for every patient post operative.
5 secondary outcomes
Total intra-operative fentanyl consumption
Time frame: 2-3 hours (Surgery time) surgery
1st time opioids requested post-operative.
Time frame: 24 hours after the surgery
Changes and stability in Mean Arterial Blood Pressure (MAP)
Time frame: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
Changes and stability in Heart Rate (HR)
Time frame: every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively
Pain scores using Visual analogue score
Time frame: 24 hours after the surgery
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 16 Jun 2026.
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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.
Ayman Sharawy Abdelrahman Aboul Nasr, MD study director
National Cancer Institute Cairo 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 Ultrasound guided bilevel Erector spinae plane block (ESPB) and Ultrasound guided Pectoserratus Block in people with Breast Cancer, run by National Cancer Institute, Egypt 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 5 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. 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?
Contact Ayman Sharawy Abdelrahman Aboul Nasr, MD (01282649008 ext. 0020, ayman.sharawy@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total post-operative morphine consumption. (time frame: 24 hours after the surgery). 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 16 Jun 2026.