Breast Neoplasm FemaleNCT06187909
PECS II vs. MTP for Analgesia After MRM
A study testing PECS II BLOCK and MTP BLOCK in people with Breast Neoplasm Female and Postoperative Pain Management, run by Ain Shams University at 1 site in Egypt.
Trial summary
This randomized controlled study aims to compare the analgesic efficacy of the ultrasound-guided modified pectoral nerve block (PECS II) and the midpoint transverse process to pleura (MTP) block in female patients undergoing modified radical mastectomy (MRM). Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Breast Neoplasm Female, Postoperative Pain Management
- What is being tested?
- PECS II BLOCK and 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
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients scheduled for modified radical mastectomy (MRM).
- Age between 40 and 65 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
Who cannot join
- Known allergy to local anesthetics.
- Coagulopathy.
- Infection at the site of injection.
- Patient refusal.
- Inability to understand or use the pain scale.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Modified Pectoral Plane (PECS II) Block Versus Midpoint Transverse Process to Pleura (MTP) Block for Postoperative Analgesia of Modified Radical Mastectomy
This randomized controlled study aims to compare the analgesic efficacy of the ultrasound-guided modified pectoral nerve block (PECS II) and the midpoint transverse process to pleura (MTP) block in female patients undergoing modified radical mastectomy (MRM). Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS) over the first 24 hours, with additional evaluation of opioid consumption and complications.
Read the detailed description
Modified radical mastectomy (MRM) is associated with significant postoperative pain, which may increase opioid use, delay recovery, and contribute to chronic post-mastectomy pain syndrome. This study compares two regional analgesic techniques: the ultrasound-guided modified pectoral nerve block (PECS II) and the midpoint transverse process to pleura (MTP) block.
The PECS II block involves the injection of local anesthetic between the pectoralis minor and serratus anterior muscles, targeting the pectoral nerves and lateral cutaneous branches of intercostal nerves (T2-T6). It is widely used for anterior chest wall analgesia after breast surgery. The MTP block, a more recent paravertebral-domain technique, deposits anesthetic midway between the transverse process and the pleura, allowing spread to dorsal and ventral rami via the superior costotransverse ligament and potentially achieving broader thoracic segment coverage.
This randomized trial evaluates postoperative pain control using the Visual Analog Scale (VAS) over 24 hours, along with opioid consumption and adverse events. The aim is to determine whether the MTP block offers superior analgesia and an opioid-sparing effect compared to the PECS II block.
- Being tested
- PECS II BLOCK, MTP BLOCK
- Keywords
- Anesthesia, Conduction, Mastectomy, Modified Radical, Breast Neoplasms, Postoperative Pain, Analgesia, Opioid, Nerve Block
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS II BLOCKProcedure or surgery
In the supine position, as described by Blanco et al., the ultrasound probe was placed transversely beneath the clavicle. After identifying the intermuscular plane between the pectoralis major and minor, 10 mL of 0.25% bupivacaine was injected. The probe was then repositioned laterally to identify the plane between the pectoralis minor and serratus anterior at the third to fourth ribs, where a further 10 mL of 0.25% bupivacaine was injected.
MTP BLOCKProcedure or surgery
The block was performed with the patient in a seated position. The ultrasound probe was positioned parasagittally, approximately 3 cm lateral to the midline, at the T2 and T6 vertebral levels. A 22-gauge needle was advanced in-plane to the midpoint between the transverse process and pleura, and 10 mL of 0.25% bupivacaine was injected at each level. This protocol was adapted from the original technique described by Bhoi et al., with modifications in injection levels and volume.
| Study group | Role | What they receive |
|---|---|---|
| PECS II block group | Active comparator | Forty-four female patients (ASA I-II, 40-65 years) scheduled for modified radical mastectomy received an ultrasound-guided PECS II block with 20 mL of 0.25% bupivacaine (10 mL between pectoralis major and minor; 10 mL between pectoralis minor and serratus anterior). Receives: Procedure: PECS II BLOCK |
| MTP block group | Active comparator | Forty-four female patients (ASA I-II, 40-65 years) scheduled for modified radical mastectomy received an ultrasound-guided midpoint transverse process to pleura (MTP) block with 20 mL of 0.25% bupivacaine (10 mL injected at T2 and 10 mL at T6). Receives: Procedure: MTP BLOCK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain Severity Assessed by VAS at Hour-4
Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome
Measured: will be evaluated at hour-4 postoperatively
Secondary outcomes (4)
Post-operative Pain Severity Assessed by VAS on Admission to Postanesthesia Care Unit (PACU), at Hour-2, Hour-8, Hour-12, Hour-18 and Hour-24.
Comparison between postoperative pain severity after 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours postoperative between both groups using visual analogue score Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome
Measured: 24 hours postoperatively
Time of First Rescue Analgesia
Comparison between both groups regarding the time of first needed dose of nalbuphine
Measured: 24 hours postoperatively
Cumulative Post-operative Nalbuphine Consumption in the First 24 Hours
Comparison between both groups regarding total consumed nalbuphine in first 24 hours postoperative
Measured: 24 hours postoperatively
Incidence of Postoperative Side Effects and Complications
Comparison between both groups regarding postoperative side effects and complications
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 Jan 2024
- Study start1 Jan 2024
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Neoplasm FemaleStudies 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
- Model description
- This study used a parallel assignment model involving 88 ASA I-II female patients undergoing modified radical mastectomy. Participants were randomized into two equal groups to receive either an ultrasound-guided PECS II block or a midpoint transverse process to pleura (MTP) block, each with 20 mL of 0.25% bupivacaine. Postoperative analgesic efficacy was assessed using the Visual Analog Scale (VAS), time to first rescue analgesia, total nalbuphine consumption, and incidence of complications over 24 hours.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed abdelghany Khalifa ragab, Ain Shams University
- Investigators
- Ahmed A. Khalifa, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187909
- Sponsor's protocol ID
- FMASU MD311/2023
- Status last verified
- Jan 2026
- First submitted
- 7 Dec 2023
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because of institutional policy and patient confidentiality concerns. Only summarized results will be made available in the published manuscript and upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Modified Pectoral Plane (PECS II) Block Versus Midpoint Transverse Process to Pleura (MTP) Block for Postoperative Analgesia of Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT06187909
- Acronym / sponsor ID
- FMASU MD311/2023
- Keywords
- Anesthesia, Conduction, Mastectomy, Modified Radical, Breast Neoplasms, Postoperative Pain, Analgesia, Opioid, Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Posted 13 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled study aims to compare the analgesic efficacy of the ultrasound-guided modified pectoral nerve block (PECS II) and the midpoint transverse process to pleura (MTP) block in female patients undergoing modified radical mastectomy (MRM). Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS) over the first 24 hours, with additional evaluation of opioid consumption and complications.
Detailed description
Modified radical mastectomy (MRM) is associated with significant postoperative pain, which may increase opioid use, delay recovery, and contribute to chronic post-mastectomy pain syndrome. This study compares two regional analgesic techniques: the ultrasound-guided modified pectoral nerve block (PECS II) and the midpoint transverse process to pleura (MTP) block.
The PECS II block involves the injection of local anesthetic between the pectoralis minor and serratus anterior muscles, targeting the pectoral nerves and lateral cutaneous branches of intercostal nerves (T2-T6). It is widely used for anterior chest wall analgesia after breast surgery. The MTP block, a more recent paravertebral-domain technique, deposits anesthetic midway between the transverse process and the pleura, allowing spread to dorsal and ventral rami via the superior costotransverse ligament and potentially achieving broader thoracic segment coverage.
This randomized trial evaluates postoperative pain control using the Visual Analog Scale (VAS) over 24 hours, along with opioid consumption and adverse events. The aim is to determine whether the MTP block offers superior analgesia and an opioid-sparing effect compared to the PECS II block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study used a parallel assignment model involving 88 ASA I-II female patients undergoing modified radical mastectomy. Participants were randomized into two equal groups to receive either an ultrasound-guided PECS II block or a midpoint transverse process to pleura (MTP) block, each with 20 mL of 0.25% bupivacaine. Postoperative analgesic efficacy was assessed using the Visual Analog Scale (VAS), time to first rescue analgesia, total nalbuphine consumption, and incidence of complications over 24 hours.
| Arm | Type | Receives |
|---|---|---|
| PECS II block group | Active comparator | Procedure: PECS II BLOCKForty-four female patients (ASA I-II, 40-65 years) scheduled for modified radical mastectomy received an ultrasound-guided PECS II block with 20 mL of 0.25% bupivacaine (10 mL between pectoralis major and minor; 10 mL between pectoralis minor and serratus anterior). |
| MTP block group | Active comparator | Procedure: MTP BLOCKForty-four female patients (ASA I-II, 40-65 years) scheduled for modified radical mastectomy received an ultrasound-guided midpoint transverse process to pleura (MTP) block with 20 mL of 0.25% bupivacaine (10 mL injected at T2 and 10 mL at T6). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients scheduled for modified radical mastectomy (MRM).
- Age between 40 and 65 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
Key exclusion criteria (5 listed)
- Known allergy to local anesthetics.
- Coagulopathy.
- Infection at the site of injection.
- Patient refusal.
- Inability to understand or use the pain scale.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PECS II BLOCKIn the supine position, as described by Blanco et al., the ultrasound probe was placed transversely beneath the clavicle. After identifying the intermuscular plane between the pectoralis major and minor, 10 mL of 0.25% bupivacaine was injected. The probe was then repositioned laterally to identify the plane between the pectoralis minor and serratus anterior at the third to fourth ribs, where a further 10 mL of 0.25% bupivacaine was injected. | Procedure or surgery | PECS II block group |
| MTP BLOCKThe block was performed with the patient in a seated position. The ultrasound probe was positioned parasagittally, approximately 3 cm lateral to the midline, at the T2 and T6 vertebral levels. A 22-gauge needle was advanced in-plane to the midpoint between the transverse process and pleura, and 10 mL of 0.25% bupivacaine was injected at each level. This protocol was adapted from the original technique described by Bhoi et al., with modifications in injection levels and volume. | Procedure or surgery | MTP block group |
Primary outcome
Post-operative Pain Severity Assessed by VAS at Hour-4
Time frame: will be evaluated at hour-4 postoperatively
Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome
4 secondary outcomes
Post-operative Pain Severity Assessed by VAS on Admission to Postanesthesia Care Unit (PACU), at Hour-2, Hour-8, Hour-12, Hour-18 and Hour-24.
Time frame: 24 hours postoperatively
Time of First Rescue Analgesia
Time frame: 24 hours postoperatively
Cumulative Post-operative Nalbuphine Consumption in the First 24 Hours
Time frame: 24 hours postoperatively
Incidence of Postoperative Side Effects and Complications
Time frame: 24 hours postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because of institutional policy and patient confidentiality concerns. Only summarized results will be made available in the published manuscript and upon reasonable request.
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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.
Ahmed A. Khalifa, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PECS II BLOCK and MTP BLOCK in people with Breast Neoplasm Female and Postoperative Pain Management, 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 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 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?
Yes. Results are posted in the registry (first posted 13 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-operative Pain Severity Assessed by VAS at Hour-4 (time frame: will be evaluated at hour-4 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 21 Jan 2026.