Modified Radical MastectomyMastectomyNCT07434232
Adding Magnesium Sulfate to Combined Pecto-Intercostal & Serratus Anterior Planes Block on Post-operative Analgesia in Patients Undergoing Modified Radical Mastectomy
A study testing combined Pecto-Intercostal- Serratus anterior fascial planes Block in people with Modified Radical Mastectomy, run by South Egypt Cancer Institute.
Trial summary
Here, in our study, we intend to compare the analgesic efficacy of magnesium sulfate as an adjuvant to local anesthetics added to the Pecto-Intercostal Fascial Block (PIFB) vs the Serratus Anterior Plane Block (SAPB) in patients undergoing modified radical mastectomy. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Modified Radical Mastectomy
- What is being tested?
- combined Pecto-Intercostal- Serratus anterior fascial planes Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 15 Apr 2027
- 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 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 30 to 75 years diagnosed with non-metastatic breast cancer and scheduled for modified radical mastectomy.
- ASA, I-III and NYHA, I-II.
- Written informed consent.
Who cannot join
- ASA physical status >III and NYHA >II,
- body mass index >40 kg/m2,
- pregnant women,
- Patients with organ failure or coagulation disorders.
- Allergy to local anesthetics or magnesium sulfate
- Contraindications as local infection
- History of chronic pain or opioid use .
- Unwilling to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
bahaa ga saad, lecturer contact
About this study
Official title: Efficacy of Adding Magnesium Sulfate to Combined Pecto-Intercostal & Serratus Anterior Planes Block on Post-operative Analgesia in Patients Undergoing Modified Radical Mastectomy: A Prospective, Randomized Controlled Clinical Trial
Here, in our study, we intend to compare the analgesic efficacy of magnesium sulfate as an adjuvant to local anesthetics added to the Pecto-Intercostal Fascial Block (PIFB) vs the Serratus Anterior Plane Block (SAPB) in patients undergoing modified radical mastectomy.
Study Endpoints Primary Endpoints: Total intravenous opioid consumption during the first 24 hours following surgery. Secondary Endpoints: Postoperative analgesia, 24 hours after surgery, assessed using the Visual Analog Scale (VAS) and time to first analgesic request.
Read the detailed description
Modified radical mastectomy, a common surgical intervention for breast cancer therapy, and is often associated with extensive postoperative pain. Effective regional anesthesia techniques are important modalities to manage this pain and reduce total opioid consumption in the early postoperative phase. A few interfacial nerve block methods (for example, pectoral nerve blocks I and II and erector spinae plane block) are also utilized in some other procedures to reduce the postoperative pain. However, these methods require particular patient positioning.
A new, minimally-invasive technique called pecto-intercostal fascial plane block (PIFB) was firstly used by De la Torre in patients who had undergone breast surgery. The Pecto-Intercostal Fascial Block (PIFB) and the Serratus Anterior Plane Block (SAPB) have appeared as promising techniques for providing pain relief in breast surgeries. PIFB targets the anterior cutaneous branches of the intercostal nerves, while SAPB focuses on the lateral cutaneous branches, each offering distinct anatomical coverage. Some specific benefits have been reported when using PIFB such as less invasiveness, proximity to the incision line, and postoperative administration with no specific patient positioning.
Recent studies have examined the efficacy of adding adjuvants to local anesthetics. Magnesium sulfate, known for its NMDA receptor antagonism and calcium channel blocking properties, has been investigated for its potency to prolong pain relief and improve analgesic control when used as an adjuvant in peripheral blocks. Evaluating the efficacy of magnesium sulfate in these fascial plane blocks may lead to the establishment of an improved standard of care in postoperative pain management.
While both PIFB and SAPB are considered safe and relatively easy to perform using ultrasound, comparative data regarding their efficacy, especially with magnesium sulfate as an adjuvant, remains limited. The outcomes of this study may help define a more effective and standardized analgesic approach for patients undergoing modified radical mastectomy. Furthermore, minimizing systemic opioid requirements is especially gaining interest considering current efforts to reduce opioid-related side effects and dependence in surgical patients.
Here, in our study, we intend to compare the analgesic efficacy of magnesium sulfate as an adjuvant to local anesthetics added to the Pecto-Intercostal Fascial Block (PIFB) vs the Serratus Anterior Plane Block (SAPB) in patients undergoing modified radical mastectomy.
Study Endpoints
- Conditions
- Modified Radical Mastectomy
- Being tested
- combined Pecto-Intercostal- Serratus anterior fascial planes Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined Pecto-Intercostal- Serratus anterior fascial planes BlockProcedure or surgery
Also called Ultrasound guided PIFB - SAPB approach
PIFB will be performed using a high-frequency linear ultrasound probe. probe should be inserted 2 cm laterally from the sternum and parallel to it. The Pecto-Intercostal Fascial plane is located between the pectoralis major muscle and the external intercostal muscle, or the costal cartilage. A 22 G 80 mm needle will be inserted under the pectoralis major and above the external intercostal muscle using the in-plane approach. Additionally, a test bolus of saline (2 mL) will be given.
For SAPB approach, patients will be positioned to the supine, and the injection sites are sterilized. The ipsilateral arm will be abducted at 90°. A high-frequency linear USG probe will be placed on the mid-axillary line in the axilla. Using an in-plane technique, a 100-mm block needle will be advanced caudo-cranially between the serratus anterior muscle and the fifth rib. After negative aspiration 1-2 mL of saline will be injected as a test dose.
| Study group | Role | What they receive |
|---|---|---|
| (Control group): | Sham comparator | patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes Block with a total volume of 30 mL local anesthetic; 15 ml per block (13.5 ml Bupivacaine 0.25% + 1.5 ml normal saline for each block). Receives: Procedure: combined Pecto-Intercostal- Serratus anterior fascial planes Block |
| (Magnesium group).: | Active comparator | where patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes block with a total of 30 ml local anesthetic volume; 15 ml per block (13.5ml bupivacaine 0.25% + 1.5 ml MgSo4 10% (100 mg/ml)) Receives: Procedure: combined Pecto-Intercostal- Serratus anterior fascial planes Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
intravenous opioid consumption
total intravenous opioid consumption during the first 24 hours
Measured: 24 hours postoperatively
Secondary outcomes (2)
pain intensity postoperatively at rest and during pain-provoking movements
postoperative pain intensity at rest and during pain-provoking movements (deep breathing, coughing, mobilization) measured by Visual analogue scale where 0= no pain, 10= worst imaginable pain
Measured: 24 hours postoperatively
First request of analgesia.
first request of opioid analgesic
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 posted25 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Apr 2027 (estimated)
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.
- 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
- Participants were randomly assigned to two groups: Group I (Control group): patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes Block with a total volume of 30 mL local anesthetic; 15 ml per block (13.5 ml Bupivacaine 0.25% + 1.5 ml normal saline for each block). Group II (Magnesium group).: where patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes block with a total of 30 ml local anesthetic volume; 15 ml per block (13.5ml bupivacaine 0.25% + 1.5 ml MgSo4 10% (100 mg/ml))
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Principal investigator, Mohammed Farghaly Abd El hamid Ahmed, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434232
- Sponsor's protocol ID
- 18-2026-810
- Acronym
- Mastectomy
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Magnesium Sulfate to Combined Pecto-Intercostal & Serratus Anterior Planes Block on Post-operative Analgesia in Patients Undergoing Modified Radical Mastectomy: A Prospective, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07434232
- Acronym / sponsor ID
- Mastectomy / 18-2026-810
- Conditions
- Modified Radical Mastectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 25 Feb 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.
Here, in our study, we intend to compare the analgesic efficacy of magnesium sulfate as an adjuvant to local anesthetics added to the Pecto-Intercostal Fascial Block (PIFB) vs the Serratus Anterior Plane Block (SAPB) in patients undergoing modified radical mastectomy.
Study Endpoints Primary Endpoints: Total intravenous opioid consumption during the first 24 hours following surgery. Secondary Endpoints: Postoperative analgesia, 24 hours after surgery, assessed using the Visual Analog Scale (VAS) and time to first analgesic request.
Detailed description
Modified radical mastectomy, a common surgical intervention for breast cancer therapy, and is often associated with extensive postoperative pain. Effective regional anesthesia techniques are important modalities to manage this pain and reduce total opioid consumption in the early postoperative phase. A few interfacial nerve block methods (for example, pectoral nerve blocks I and II and erector spinae plane block) are also utilized in some other procedures to reduce the postoperative pain. However, these methods require particular patient positioning.
A new, minimally-invasive technique called pecto-intercostal fascial plane block (PIFB) was firstly used by De la Torre in patients who had undergone breast surgery. The Pecto-Intercostal Fascial Block (PIFB) and the Serratus Anterior Plane Block (SAPB) have appeared as promising techniques for providing pain relief in breast surgeries. PIFB targets the anterior cutaneous branches of the intercostal nerves, while SAPB focuses on the lateral cutaneous branches, each offering distinct anatomical coverage. Some specific benefits have been reported when using PIFB such as less invasiveness, proximity to the incision line, and postoperative administration with no specific patient positioning.
Recent studies have examined the efficacy of adding adjuvants to local anesthetics. Magnesium sulfate, known for its NMDA receptor antagonism and calcium channel blocking properties, has been investigated for its potency to prolong pain relief and improve analgesic control when used as an adjuvant in peripheral blocks. Evaluating the efficacy of magnesium sulfate in these fascial plane blocks may lead to the establishment of an improved standard of care in postoperative pain management.
While both PIFB and SAPB are considered safe and relatively easy to perform using ultrasound, comparative data regarding their efficacy, especially with magnesium sulfate as an adjuvant, remains limited. The outcomes of this study may help define a more effective and standardized analgesic approach for patients undergoing modified radical mastectomy. Furthermore, minimizing systemic opioid requirements is especially gaining interest considering current efforts to reduce opioid-related side effects and dependence in surgical patients.
Here, in our study, we intend to compare the analgesic efficacy of magnesium sulfate as an adjuvant to local anesthetics added to the Pecto-Intercostal Fascial Block (PIFB) vs the Serratus Anterior Plane Block (SAPB) in patients undergoing modified radical mastectomy.
Study Endpoints
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to two groups: Group I (Control group): patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes Block with a total volume of 30 mL local anesthetic; 15 ml per block (13.5 ml Bupivacaine 0.25% + 1.5 ml normal saline for each block). Group II (Magnesium group).: where patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes block with a total of 30 ml local anesthetic volume; 15 ml per block (13.5ml bupivacaine 0.25% + 1.5 ml MgSo4 10% (100 mg/ml))
| Arm | Type | Receives |
|---|---|---|
| (Control group): | Sham comparator | Procedure: combined Pecto-Intercostal- Serratus anterior fascial planes Blockpatients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes Block with a total volume of 30 mL local anesthetic; 15 ml per block (13.5 ml Bupivacaine 0.25% + 1.5 ml normal saline for each block). |
| (Magnesium group).: | Active comparator | Procedure: combined Pecto-Intercostal- Serratus anterior fascial planes Blockwhere patients will receive the combined Pecto-Intercostal- Serratus anterior fascial planes block with a total of 30 ml local anesthetic volume; 15 ml per block (13.5ml bupivacaine 0.25% + 1.5 ml MgSo4 10% (100 mg/ml)) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients aged 30 to 75 years diagnosed with non-metastatic breast cancer and scheduled for modified radical mastectomy.
- ASA, I-III and NYHA, I-II.
- Written informed consent.
Key exclusion criteria (8 listed)
- ASA physical status >III and NYHA >II,
- body mass index >40 kg/m2,
- pregnant women,
- Patients with organ failure or coagulation disorders.
- Allergy to local anesthetics or magnesium sulfate
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 |
|---|---|---|
| combined Pecto-Intercostal- Serratus anterior fascial planes BlockAlso: Ultrasound guided PIFB - SAPB approachPIFB will be performed using a high-frequency linear ultrasound probe. probe should be inserted 2 cm laterally from the sternum and parallel to it. The Pecto-Intercostal Fascial plane is located between the pectoralis major muscle and the external intercostal muscle, or the costal cartilage. A 22 G 80 mm needle will be inserted under the pectoralis major and above the external intercostal muscle using the in-plane approach. Additionally, a test bolus of saline (2 mL) will be given. For SAPB approach, patients will be positioned to the supine, and the injection sites are sterilized. The ipsilateral arm will be abducted at 90°. A high-frequency linear USG probe will be placed on the mid-axillary line in the axilla. Using an in-plane technique, a 100-mm block needle will be advanced caudo-cranially between the serratus anterior muscle and the fifth rib. After negative aspiration 1-2 mL of saline will be injected as a test dose. | Procedure or surgery | (Control group):, (Magnesium group).: |
Primary outcome
intravenous opioid consumption
Time frame: 24 hours postoperatively
total intravenous opioid consumption during the first 24 hours
2 secondary outcomes
pain intensity postoperatively at rest and during pain-provoking movements
Time frame: 24 hours postoperatively
First request of analgesia.
Time frame: 24 hours postoperatively
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 25 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Modified Radical Mastectomy
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Perioperative Mirogabalin for Pain Relief After Modified Radical Mastectomy
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Ultrasound-Guided SPSIP Versus ESPB for Postoperative Pain After Modified Radical Mastectomy
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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.
bahaa ga saad, lecturer contact
Questions about this trial
What is this clinical trial studying?
A study testing combined Pecto-Intercostal- Serratus anterior fascial planes Block in people with Modified Radical Mastectomy, run by South Egypt Cancer Institute.
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: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 mohamed fa abd elhamed, lecture (01015249890 ext. 02, m.farghaly.na@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intravenous opioid consumption (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 25 Feb 2026.