Breast CancerNCT06888258
Compare Analgesia Between MTP Block And ESPB in MRM
A study testing Ultrasound guided Erector Spinae Plane block and Ultrasound guided Mid-point to Pleura block in people with Breast Cancer, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
This study is conducted to compare the analgesic efficacy between ultrasound guided Erector Spinae Plane block Vs midpoint transverse process to Pleura block in modified radical mastectomy surgeries Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ultrasound guided Erector Spinae Plane block and Ultrasound guided Mid-point to Pleura block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Feb 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II.
- Undergoing modified radical mastectomy surgery.
- Body mass index (BMI) from 18.5 to 30 kg/m2
Who cannot join
- Patient refusal.
- Known allergy to local anesthetics.
- Bleeding disorders; platelets count <50,000 , prothrombin concentration < 60% or any coagulopathy disorder.
- Use of any anti-coagulants.
- Inability to provide informed consent.
- ASA III-IV.
- Neurological disorders.
- Patient with psychiatric disorders
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
Zainab Korany, +20 10 21419716, irb@nci.cu.edu.eg
About this study
Official title: Comparative Study Between Ultrasound Guided Mid-point Transverse Process to Pleura Block And Erector Spinae Plane Block For Perioperative Analgesia In Modified Radical Mastectomy In Breast Cancer Patients
This study is conducted to compare the analgesic efficacy between ultrasound guided Erector Spinae Plane block Vs midpoint transverse process to Pleura block in modified radical mastectomy surgeries
Read the detailed description
Patients participants will be randomized into 3 groups:
Group M (mid-point transverse process to pleura block MTP) N=3o Patients will receive Ultrasound guided mid-point transverse process to pleura block preoperative with injection of 20 ml bupivacaine 0.25%.
Group M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura.
A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4th and 5th thoracic vertebrae, the puncture needle needle tip will be placed at the mid-point between the transverse process and pleura, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered. The local anesthetic spread will be noted in the area midway between the transverse process and pleura is an indication of a successful puncture.
Group E (Erector Spinae Plane Block ESB) N=3o Patients will receive Ultrasound guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.
Group E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle.
A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaesthesia infiltration. A 20-gauge Tuohy needle connected to a syringe containing the anesthetic mixture or saline will be advanced. When the puncture needle touch the transverse process, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered between the erector spine muscle and transverse process.
Local anesthetic diffusion between the transverse process and erector spinae muscle is an indication of a successful puncture.
Group C (control group) N=30 Patients will not receive any block. Induction will be performed by using a regimen of IV by fentanyl 1 μg/kg, Additional bolus doses of fentanyl 0.5 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.
- Conditions
- Breast Cancer
- Being tested
- Ultrasound guided Erector Spinae Plane block, Ultrasound guided Mid-point to Pleura block
- 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 Erector Spinae Plane blockProcedure or surgery
Group E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle.
A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaesthesia infiltration. A 20-gauge Tuohy needle connected to a syringe containing the anesthetic mixture or saline will be advanced. When the puncture needle touch the transverse process, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered between the erector spine muscle and transverse process.
Local anesthetic diffusion between the transverse process and erector spinae muscle is an indication of a successful puncture.
Ultrasound guided Mid-point to Pleura blockProcedure or surgery
Group M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura.
A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4th and 5th thoracic vertebrae, the puncture needle needle tip will be placed at the mid-point between the transverse process and pleura, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered. The local anesthetic spread will be noted in the area midway between the transverse process and pleura is an indication of a successful puncture.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane block arm | Active comparator | Group E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle.
A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaesthesia infiltration. A 20-gauge Tuohy needle connected to a syringe containing the anesthetic mixture or saline will be advanced. When the puncture needle touch the transverse process, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered between the erector spine muscle and transverse process.
Local anesthetic diffusion between the transverse process and erector spinae muscle is an indication of a successful puncture. Receives: Procedure: Ultrasound guided Erector Spinae Plane block |
| Mid-point Transverse Process to Pleura block arm | Active comparator | Group M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura.
A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4th and 5th thoracic vertebrae, the puncture needle needle tip will be placed at the mid-point between the transverse process and pleura, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered. The local anesthetic spread will be noted in the area midway between the transverse process and pleura is an indication of a successful puncture. Receives: Procedure: Ultrasound guided Mid-point to Pleura block |
| Control arm | No intervention | Patients in this arm will not receive block but they will receive Intravenous morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative opioid (morphine) consumption in the 1st 24 hours
Total post operative morphine dosage in mg required
Measured: 24 hours
Secondary outcomes (7)
Time to first rescue analgesia, starting after extubation. In minutes
When was the first rescue analgesia given
Measured: 24 hours
Total dose of fentanyl required intraoperative (including induction dose) in microgram
Total fentanyl dose given intraoperative
Measured: 24 hours
Numerical pain rating score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery. Score from 0 to 10 where 10 is the worst pain
Pain score post operative
Measured: 24 hours
Change in heart rate (rate per minute) intraoperatively at 30 minutes interval in comparison to baseline reading.
Change in vital data intraoperative
Measured: 24 hours
Change mean arterial blood pressure (mmHg) intraoperatively at 30 minutes interval in comparison to baseline reading.
Change in vital data intraoperative
Measured: 24 hours
Heart rate (per minute) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively
Post operative vital data
Measured: 24 hours
Mean arterial blood pressure (mmHg) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively
Post operative vital data
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Oct 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Feb 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maie Kamal El-Din Helaly, MD, Study director, National cancer institute, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888258
- Sponsor's protocol ID
- AP2407-201-014
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2025
- Last updated
- 26 Mar 2025
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Ultrasound Guided Mid-point Transverse Process to Pleura Block And Erector Spinae Plane Block For Perioperative Analgesia In Modified Radical Mastectomy In Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06888258
- Acronym / sponsor ID
- AP2407-201-014
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 21 Mar 2025 (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.
This study is conducted to compare the analgesic efficacy between ultrasound guided Erector Spinae Plane block Vs midpoint transverse process to Pleura block in modified radical mastectomy surgeries
Detailed description
Patients participants will be randomized into 3 groups:
Group M (mid-point transverse process to pleura block MTP) N=3o Patients will receive Ultrasound guided mid-point transverse process to pleura block preoperative with injection of 20 ml bupivacaine 0.25%.
Group M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura.
A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4th and 5th thoracic vertebrae, the puncture needle needle tip will be placed at the mid-point between the transverse process and pleura, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered. The local anesthetic spread will be noted in the area midway between the transverse process and pleura is an indication of a successful puncture.
Group E (Erector Spinae Plane Block ESB) N=3o Patients will receive Ultrasound guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.
Group E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle.
A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaesthesia infiltration. A 20-gauge Tuohy needle connected to a syringe containing the anesthetic mixture or saline will be advanced. When the puncture needle touch the transverse process, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered between the erector spine muscle and transverse process.
Local anesthetic diffusion between the transverse process and erector spinae muscle is an indication of a successful puncture.
Group C (control group) N=30 Patients will not receive any block. Induction will be performed by using a regimen of IV by fentanyl 1 μg/kg, Additional bolus doses of fentanyl 0.5 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane block arm | Active comparator | Procedure: Ultrasound guided Erector Spinae Plane blockGroup E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle. A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaesthesia infiltration. A 20-gauge Tuohy needle connected to a syringe containing the anesthetic mixture or saline will be advanced. When the puncture needle touch the transverse process, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered between the erector spine muscle and transverse process. Local anesthetic diffusion between the transverse process and erector spinae muscle is an indication of a successful puncture. |
| Mid-point Transverse Process to Pleura block arm | Active comparator | Procedure: Ultrasound guided Mid-point to Pleura blockGroup M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura. A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4th and 5th thoracic vertebrae, the puncture needle needle tip will be placed at the mid-point between the transverse process and pleura, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered. The local anesthetic spread will be noted in the area midway between the transverse process and pleura is an indication of a successful puncture. |
| Control arm | No intervention | –Patients in this arm will not receive block but they will receive Intravenous morphine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I-II.
- Undergoing modified radical mastectomy surgery.
- Body mass index (BMI) from 18.5 to 30 kg/m2
Key exclusion criteria (8 listed)
- Patient refusal.
- Known allergy to local anesthetics.
- Bleeding disorders; platelets count <50,000 , prothrombin concentration < 60% or any coagulopathy disorder.
- Use of any anti-coagulants.
- Inability to provide informed consent.
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 Erector Spinae Plane blockGroup E: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse process of the 5th thoracic vertebra and erector spine muscle. A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. The puncture will be performed using the intra-plane needling technique after local anaesthesia infiltration. A 20-gauge Tuohy needle connected to a syringe containing the anesthetic mixture or saline will be advanced. When the puncture needle touch the transverse process, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered between the erector spine muscle and transverse process. Local anesthetic diffusion between the transverse process and erector spinae muscle is an indication of a successful puncture. | Procedure or surgery | Erector Spinae Plane block arm |
| Ultrasound guided Mid-point to Pleura blockGroup M: The block will be performed preoperatively with full aseptic precautions. The ultrasound probe will be placed on the back in a vertical orientation on the lateral side of the posterior median line to identify the transverse processes of the 4th and 5th thoracic vertebrae and pleura. A skin wheal using 3ml of 1% lidocaine will be made 2 to 3 cm superior to the superior aspect of the transducer. Using the in plane needling technique in the space between the transverse processes of the 4th and 5th thoracic vertebrae, the puncture needle needle tip will be placed at the mid-point between the transverse process and pleura, with no blood, gas, or cerebrospinal fluid observed on aspiration, 20 mL of 0.25% bupivacaine will be administered. The local anesthetic spread will be noted in the area midway between the transverse process and pleura is an indication of a successful puncture. | Procedure or surgery | Mid-point Transverse Process to Pleura block arm |
Primary outcome
post-operative opioid (morphine) consumption in the 1st 24 hours
Time frame: 24 hours
Total post operative morphine dosage in mg required
7 secondary outcomes
Time to first rescue analgesia, starting after extubation. In minutes
Time frame: 24 hours
Total dose of fentanyl required intraoperative (including induction dose) in microgram
Time frame: 24 hours
Numerical pain rating score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery. Score from 0 to 10 where 10 is the worst pain
Time frame: 24 hours
Change in heart rate (rate per minute) intraoperatively at 30 minutes interval in comparison to baseline reading.
Time frame: 24 hours
Change mean arterial blood pressure (mmHg) intraoperatively at 30 minutes interval in comparison to baseline reading.
Time frame: 24 hours
Heart rate (per minute) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively
Time frame: 24 hours
Mean arterial blood pressure (mmHg) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively
Time frame: 24 hours
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 26 Mar 2025.
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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.
Maie Kamal El-Din Helaly, 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 Erector Spinae Plane block and Ultrasound guided Mid-point to Pleura 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 3 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: looking for participants now, as of the sponsor's last update on 26 Mar 2025. 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 mahmoud Saad Mahmoud Mohamed Mohamed, Msc (+201094555375, doc.mahmoudsaad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative opioid (morphine) consumption in the 1st 24 hours (time frame: 24 hours). 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 26 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.