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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PECS II BLOCK | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | will be evaluated at hour-4 postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Study population restricted to female patients undergoing modified radical mastectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed A. Khalifa, MD | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
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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Out of 112 screened patients, 24 were excluded (17 did not meet inclusion criteria, 7 declined participation), leaving 88 enrolled and randomly allocated to Group A (PECS II block, n=44) and Group B (MTP block, n=44).
Four participants withdrew consent during follow-up, resulting in 84 completions (42 per group). All remaining participants were included in the final analysis, with no exclusions
This was a single-center, prospective, randomized controlled trial conducted at Ain Shams University Hospital. A total of 112 patients scheduled for modified radical mastectomy were assessed for eligibility between November 2023 and July 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | MTP Block Group | Forty-four ASA I-II female patients, aged 40-65 years and scheduled for modified radical mastectomy, received an ultrasound-guided midpoint transverse process to pleura (MTP) block. A high-frequency linear probe was placed parasagittally, approximately 3 cm lateral to the midline at the T2 and T6 vertebral levels. A 22-gauge echogenic 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. |
| FG001 | PECS II Block Group | Forty-four ASA I-II female patients, aged 40-65 years and scheduled for modified radical mastectomy, received an ultrasound-guided PECS II block. A high-frequency linear probe was placed beneath the clavicle to identify the intermuscular plane between the pectoralis major and minor, where 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 level of the third to fourth ribs, where another 10 mL of 0.25% bupivacaine was injected. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | MTP Block Group | Forty-four ASA I-II female patients, aged 40-65 years and scheduled for modified radical mastectomy, received an ultrasound-guided midpoint transverse process to pleura (MTP) block. A high-frequency linear probe was positioned parasagittally about 3 cm lateral to the midline at the T2 and T6 vertebral levels. A 22-gauge needle was advanced in-plane, and 10 mL of 0.25% bupivacaine was injected at each level. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | will be evaluated at hour-4 postoperatively |
|
24 hours postoperatively
Adverse events included block-related complications: vascular puncture, pneumothorax, and local anesthetic systemic toxicity. Events were assessed by anesthesiologists intraoperatively and during the first 24 hours after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MTP Block Group | Forty-four ASA I-II female patients, aged 40-65 years and scheduled for modified radical mastectomy received an ultrasound-guided midpoint transverse process to pleura (MTP) block. A high-frequency linear probe was positioned parasagittally about 3 cm lateral to the midline at the T2 and T6 vertebral levels. A 22-gauge echogenic 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yasser Mohamed Reyad Ahmed El-Mansoury | Department of Anesthesia, Intensive Care, and Pain Management, Faculty of Medicine, Ain Shams University, Cairo, Egypt | 01000286206 | yassermoahmed0102107@med.asu.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2023 | Dec 30, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
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Patients were sedated during block placement; however, due to the distinct anatomical sites of the two techniques, full patient blinding could not be ensured. Outcome assessors gathering postoperative data were blinded to group allocation, and the anesthesiologists performing the blocks were not engaged in data collection.
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| MTP BLOCK | Procedure | 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. |
|
| 24 hours postoperatively |
| Time of First Rescue Analgesia | Comparison between both groups regarding the time of first needed dose of nalbuphine | 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 | 24 hours postoperatively |
| Incidence of Postoperative Side Effects and Complications | Comparison between both groups regarding postoperative side effects and complications | 24 hours postoperatively |
| BG001 | PECS II Block Group | Forty-four ASA I-II female patients, aged 40-65 years and scheduled for modified radical mastectomy, received an ultrasound-guided PECS II block with 20 mL of 0.25% bupivacaine (10 mL between the pectoralis major and minor, and 10 mL between the pectoralis minor and serratus anterior at the third to fourth ribs). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| weight | Mean | Standard Deviation | kilograms |
|
| height | Mean | Standard Deviation | meters |
|
| body mass index | Mean | Standard Deviation | kilograms per meter square |
|
| PECS II Block Group |
Forty-four ASA I-II female patients, aged 40-65 years and scheduled for modified radical mastectomy, received an ultrasound-guided PECS II block. Using a high-frequency linear probe, 10 mL of 0.25% bupivacaine was injected between the pectoralis major and minor muscles. The probe was then repositioned laterally to the plane between the pectoralis minor and serratus anterior at the third to fourth ribs, where another 10 mL of 0.25% bupivacaine was injected. |
|
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| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | 24 hours postoperatively |
|
|
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| Secondary | Time of First Rescue Analgesia | Comparison between both groups regarding the time of first needed dose of nalbuphine | Posted | Mean | Standard Deviation | hours | 24 hours postoperatively |
|
|
|
| Secondary | Cumulative Post-operative Nalbuphine Consumption in the First 24 Hours | Comparison between both groups regarding total consumed nalbuphine in first 24 hours postoperative | Posted | Mean | Standard Deviation | milligrams | 24 hours postoperatively |
|
|
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| Secondary | Incidence of Postoperative Side Effects and Complications | Comparison between both groups regarding postoperative side effects and complications | Posted | Count of Participants | Participants | 24 hours postoperatively |
|
|
|
| 0 |
| 42 |
| 1 |
| 42 |
| 12 |
| 42 |
| EG001 | PECS II Block Group | Forty-four ASA I-II female patients, aged 40-65 years and scheduled for modified radical mastectomy, received an ultrasound-guided PECS II block. Using a high-frequency linear probe, 10 mL of 0.25% bupivacaine was injected between the pectoralis major and minor muscles. The probe was then repositioned laterally to the plane between the pectoralis minor and serratus anterior at the third to fourth ribs, where another 10 mL of 0.25% bupivacaine was injected. | 0 | 42 | 0 | 42 | 23 | 42 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Post-operative pain severity assessed by Visual analogue scale at 8 hours postoperatively. |
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| Post-operative pain severity assessed by Visual analogue scale at 12 hours postoperatively. |
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| Post-operative pain severity assessed by Visual analogue scale at 18 hours postoperatively. |
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| Post-operative pain severity assessed by Visual analogue scale at 24 hours postoperatively. |
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| vomiting |
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| pneumothorax |
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