Modified Radical MastectomyNCT06625879
Mid-point Transverse Process to Pleura Block VS Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy
A study testing Serratus Anterior Plane Block (SAPB) and Midpoint transverse process to pleura (MTP) block in people with Modified Radical Mastectomy and Postoperative Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aimed to compare the analgesic efficacy of ultrasound-guided mid-point transverse process-to-pleura block versus serratus anterior plane block after unilateral modified radical mastectomy. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Modified Radical Mastectomy, Postoperative Analgesia, Mid-point Transverse Process to Pleura Block
- What is being tested?
- Serratus Anterior Plane Block (SAPB) and Midpoint transverse process to pleura (MTP) block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 1 Nov 2025
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients undergoing unilateral Modified Radical Mastectomy. Physical status: ASA grades I and II. Age between 35 and 60 years old.
Who cannot join
- Known Allergy to one of the study drugs. Asthmatic patients. Patients undergoing bilateral Modified Radical Mastectomy. Patients refusal of procedure or participation in the study. ASA classes III or above. Local skin infection at the site of the block. Pregnant Patients. Other malignancy. History or evidence of coagulopathy. History of use of anti coagulant or anti platelet therapy. Body mass index ≥40 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Mid-point Transverse Process to Pleura Block Versus Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy as a Randomized Trial
This study aimed to compare the analgesic efficacy of ultrasound-guided mid-point transverse process-to-pleura block versus serratus anterior plane block after unilateral modified radical mastectomy.
Read the detailed description
Breast cancer is the most common cancer in women both in the developed and less developed world. In 2012, it represented about 12 percent of all new cancer cases and 25 percent of all cancers in women.
After the application of ultrasound in anaesthetic practice, several blocks have been described recently, Serratus anterior plane blocks performed at the axillary fossa within a region bounded by the anterior and posterior axillary lines and th 3rd to 6th ribs, in which the intercostobrachialis nerve, lateral cutaneous branches of the intercostal nerves (T2-T9),long thoracic nerve, and the thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles.
The MTP block is a new block described for thoracic surgery, it involves deposition of the local anesthetic drug midway between the transverse process and the pleura. Postulated that the local anesthetic deposited at this point will reach the paravertebral space through several possible mechanisms, such as medially through the gap between the superior costotransverse ligament (SCTL) and vertebral bodies, through fenestrations in SCTL, and laterally through the internal intercostal membrane, the neural target will be the dorsal and ventral rami of spinal nerves, spanning 1-3 levels cranial and caudal to the level of injection, the advantage of the MTP block over the conventional thoracic paravertebral block is that the visualization of SCTL is not required, which might be difficult in patients with obesity. The second advantage is that the target point of the needle is very superficial and far from structures, such as the pleura and neurovascular bundles ,making this novel block much safer.
- Conditions
- Modified Radical Mastectomy, Postoperative Analgesia, Mid-point Transverse Process to Pleura Block, Serratus Anterior Plane Block
- Being tested
- Serratus Anterior Plane Block (SAPB), Midpoint transverse process to pleura (MTP) block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Anterior Plane Block (SAPB)Procedure or surgery
Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15):
The patient will lay on her side with arm brought forward, the linear US transducer probe (10-12 MHz) will be placed in the midaxillary line and then moved caudal from second rib until the sixth intercostal space. At this point, the subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction. In-plane technique will be used until the tip of the needle placed between the serratus anterior muscle and the external intercostal muscle (deep SABP) . A volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection.
Midpoint transverse process to pleura (MTP) blockProcedure or surgery
In the lateral postion, the T4 spine will be counted by ultrasound, and high frequency linear US transducer probe (10-12 MHz) will be placed longitudinally, approximately 2.5 cm lateral to the midline the needle will be advanced in plane from cranial to caudal direction. The desired end point for the needle tip will be the midpoint of the line between the posterior border of the transverse process of T4 and the pleura(injection will be deep (anterior) to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligment),the needle tip dose not enter the paravertebral space , a volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection,pleural displacement and bowing of erector spinae will be observed at the side of injection .
| Study group | Role | What they receive |
|---|---|---|
| Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15) | Active comparator | Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15):
The patient will lay on her side with arm brought forward, the linear US transducer probe (10-12 MHz) will be placed in the midaxillary line and then moved caudal from second rib until the sixth intercostal space. At this point, the subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction. In-plane technique will be used until the tip of the needle placed between the serratus anterior muscle and the external intercostal muscle (deep SABP) (Blanco et al., 2013). A volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection (Lin J et al., 2020). Receives: Procedure: Serratus Anterior Plane Block (SAPB) |
| GroupII: (Midpoint transverse process to pleura (MTP) block group )(n=15) | Active comparator | GroupII: (Midpoint transverse process to pleura (MTP) block group )(n=15):
In the lateral postion, the T4 spine will be counted by ultrasound, and high frequency linear US transducer probe (10-12 MHz) will be placed longitudinally, approximately 2.5 cm lateral to the midline the needle will be advanced in plane from cranial to caudal direction. The desired end point for the needle tip will be the midpoint of the line between the posterior border of the transverse process of T4 and the pleura(injection will be deep (anterior) to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligment),the needle tip dose not enter the paravertebral space (Chin et al., 2021), a volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection,pleural displacement and bowing of erector spinae will be observed at the side of injection (Syal et al., 2020; Pusch et al., 2000). Receives: Procedure: Midpoint transverse process to pleura (MTP) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia
Time to first rescue analgesia was recorded from the end of surgery to first diclofenac administration.
Measured: 24 hours postoperatively
Secondary outcomes (7)
The total number of doses of the rescue analgesia
The total number of doses of the rescue analgesia that was received in the 24 hours postoperatively if the NRS pain score at rest ≥4, Numeric Rating Scale (NRS) at rest and at movement (cough or rotating the body).
Measured: 24 hours postoperatively
Degree of pain
Pain was assessed using an 11-point Numeric Rating Scale (NRS) (0=no pain, 1-3 mild, 4-7 moderate, 7-10 severe) at rest and during movement. Pain scores were recorded at 0, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.
Measured: 24 hours postoperatively
Objective Pain Score
Objective Pain Score (OPS) was used to assess the degree of pain (1=inadequate pain relief/pain at rest; 2=pain-free at rest but pain with deep breathing; 3=pain-free with deep breathing but pain with coughing; 4=pain-free even with coughing).
Measured: 24 hours postoperatively
Heart rate
Heart rate was recorded at baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.
Measured: 24 hours postoperatively
Mean arterial pressure
Mean arterial pressure was recorded at baseline, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as nausea and vomiting were recorded.
Measured: 24 hours postoperatively
Incidence of block-related complications
Incidence of block-related complications such as local anesthetic toxicity and pneumothorax were recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modified Radical MastectomyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ashraf Hassan Abd Elsalam, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625879
- Sponsor's protocol ID
- FMASU MD325/2023
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2024
- Last updated
- 7 Oct 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Mid-point Transverse Process to Pleura Block Versus Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy as a Randomized Trial
- ClinicalTrials.gov ID
- NCT06625879
- Acronym / sponsor ID
- FMASU MD325/2023
- Conditions
- Modified Radical Mastectomy, Postoperative Analgesia, Mid-point Transverse Process to Pleura Block, Serratus Anterior Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 3 Oct 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.
This study aimed to compare the analgesic efficacy of ultrasound-guided mid-point transverse process-to-pleura block versus serratus anterior plane block after unilateral modified radical mastectomy.
Detailed description
Breast cancer is the most common cancer in women both in the developed and less developed world. In 2012, it represented about 12 percent of all new cancer cases and 25 percent of all cancers in women.
After the application of ultrasound in anaesthetic practice, several blocks have been described recently, Serratus anterior plane blocks performed at the axillary fossa within a region bounded by the anterior and posterior axillary lines and th 3rd to 6th ribs, in which the intercostobrachialis nerve, lateral cutaneous branches of the intercostal nerves (T2-T9),long thoracic nerve, and the thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles.
The MTP block is a new block described for thoracic surgery, it involves deposition of the local anesthetic drug midway between the transverse process and the pleura. Postulated that the local anesthetic deposited at this point will reach the paravertebral space through several possible mechanisms, such as medially through the gap between the superior costotransverse ligament (SCTL) and vertebral bodies, through fenestrations in SCTL, and laterally through the internal intercostal membrane, the neural target will be the dorsal and ventral rami of spinal nerves, spanning 1-3 levels cranial and caudal to the level of injection, the advantage of the MTP block over the conventional thoracic paravertebral block is that the visualization of SCTL is not required, which might be difficult in patients with obesity. The second advantage is that the target point of the needle is very superficial and far from structures, such as the pleura and neurovascular bundles ,making this novel block much safer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15) | Active comparator | Procedure: Serratus Anterior Plane Block (SAPB)Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15): The patient will lay on her side with arm brought forward, the linear US transducer probe (10-12 MHz) will be placed in the midaxillary line and then moved caudal from second rib until the sixth intercostal space. At this point, the subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction. In-plane technique will be used until the tip of the needle placed between the serratus anterior muscle and the external intercostal muscle (deep SABP) (Blanco et al., 2013). A volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection (Lin J et al., 2020). |
| GroupII: (Midpoint transverse process to pleura (MTP) block group )(n=15) | Active comparator | Procedure: Midpoint transverse process to pleura (MTP) blockGroupII: (Midpoint transverse process to pleura (MTP) block group )(n=15): In the lateral postion, the T4 spine will be counted by ultrasound, and high frequency linear US transducer probe (10-12 MHz) will be placed longitudinally, approximately 2.5 cm lateral to the midline the needle will be advanced in plane from cranial to caudal direction. The desired end point for the needle tip will be the midpoint of the line between the posterior border of the transverse process of T4 and the pleura(injection will be deep (anterior) to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligment),the needle tip dose not enter the paravertebral space (Chin et al., 2021), a volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection,pleural displacement and bowing of erector spinae will be observed at the side of injection (Syal et al., 2020; Pusch et al., 2000). |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients undergoing unilateral Modified Radical Mastectomy. Physical status: ASA grades I and II. Age between 35 and 60 years old.
Key exclusion criteria (1 listed)
- Known Allergy to one of the study drugs. Asthmatic patients. Patients undergoing bilateral Modified Radical Mastectomy. Patients refusal of procedure or participation in the study. ASA classes III or above. Local skin infection at the site of the block. Pregnant Patients. Other malignancy. History or evidence of coagulopathy. History of use of anti coagulant or anti platelet therapy. Body mass index ≥40 kg/m2.
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 |
|---|---|---|
| Serratus Anterior Plane Block (SAPB)Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15): The patient will lay on her side with arm brought forward, the linear US transducer probe (10-12 MHz) will be placed in the midaxillary line and then moved caudal from second rib until the sixth intercostal space. At this point, the subcutaneous tissue and serratus muscle will be identified in the superficial plane, whereas the external intercostal muscles will be identified in the intermediate plane and finally in the deep plane the ribs, pleura and lung will be identified. The needle will be advanced from caudal to cranial direction. In-plane technique will be used until the tip of the needle placed between the serratus anterior muscle and the external intercostal muscle (deep SABP) . A volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection. | Procedure or surgery | Group I: (Serratus Anterior Plane Block (SAPB) Group) (n=15) |
| Midpoint transverse process to pleura (MTP) blockIn the lateral postion, the T4 spine will be counted by ultrasound, and high frequency linear US transducer probe (10-12 MHz) will be placed longitudinally, approximately 2.5 cm lateral to the midline the needle will be advanced in plane from cranial to caudal direction. The desired end point for the needle tip will be the midpoint of the line between the posterior border of the transverse process of T4 and the pleura(injection will be deep (anterior) to the posterior aspect of the vertebral transverse process but superficial to the superior costotransverse ligment),the needle tip dose not enter the paravertebral space , a volume of titrated bolus of 20 ml of bupivacaine 0.5% will be injected after aspiration to avoid intravascular injection,pleural displacement and bowing of erector spinae will be observed at the side of injection . | Procedure or surgery | GroupII: (Midpoint transverse process to pleura (MTP) block group )(n=15) |
Primary outcome
Time to first rescue analgesia
Time frame: 24 hours postoperatively
Time to first rescue analgesia was recorded from the end of surgery to first diclofenac administration.
7 secondary outcomes
The total number of doses of the rescue analgesia
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Objective Pain Score
Time frame: 24 hours postoperatively
Heart rate
Time frame: 24 hours postoperatively
Mean arterial pressure
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
Incidence of block-related complications
Time frame: 24 hours postoperatively
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 7 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus Anterior Plane Block (SAPB) and Midpoint transverse process to pleura (MTP) block in people with Modified Radical Mastectomy and Postoperative Analgesia, run by Ain Shams 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 1 inclusion and 1 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 7 Oct 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?
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?
Time to first rescue analgesia (time frame: 24 hours postoperatively). 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 7 Oct 2026.