Post-mastectomy Pain SyndromeNCT07438366
Adding Magnesium Sulphate to Combined Pectointercostal Plane and Erector Spinae Plane Blocks for Acute and Chronic Post-Mastectomy Pain
A study testing Pectointercostal Plane Block (PIPB), Erector Spinae Plane Block (ESPB) and Magnesium sulfate in people with Post-mastectomy Pain Syndrome, run by South Egypt Cancer Institute.
Trial summary
Given the burden of chronic postmastectomy pain and the need for effective, opioid-sparing analgesia, the propose of the randomized controlled trial is to evaluate the safety and efficacy of adding magnesium sulphate to the combination of PIP block and ESPB in patients undergoing modified radical mastectomy for… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post-mastectomy Pain Syndrome
- What is being tested?
- Pectointercostal Plane Block (PIPB), Erector Spinae Plane Block (ESPB) and Magnesium sulfate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 15 Feb 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years.
- American Society of Anesthesiologists (ASA) class I-III.
- Scheduled for unilateral modified radical mastectomy.
Who cannot join
- Known allergy to local anesthetics or magnesium.
- Coagulopathy or anticoagulant therapy.
- Local infection at injection site.
- Body mass index (BMI) ≥ 40 kg/m2.
- Chronic opioid use or chronic pain disorders.
- Neurological or psychiatric disorders affect pain perception.
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- Severe hepatic or renal impairment.
- Pregnancy.
- Lactation.
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 Sulphate to Combined Pectointercostal Plane Block and Erector Spinae Plane Block for Acute and Chronic Post-Mastectomy Pain After Modified Radical Mastectomy. A Controlled Clinical Trial
Given the burden of chronic postmastectomy pain and the need for effective, opioid-sparing analgesia, the propose of the randomized controlled trial is to evaluate the safety and efficacy of adding magnesium sulphate to the combination of PIP block and ESPB in patients undergoing modified radical mastectomy for reducing acute and chronic post mastectomy pain
Read the detailed description
Breast cancer remains one of the most common malignancies worldwide, and modified radical mastectomy (MRM) continues to be a mainstay surgical treatment in many cases. However, postoperative pain after MRM can be significant, both in the acute period and long-term, contributing to persistent pain syndromes, impaired recovery, and reduced quality of life. Regional anesthesia techniques such as the pectointercostal plane (PIPB) block and erector spinae plane block (ESPB) have gained wide acceptance as effective approaches to reduce perioperative analgesic requirements, improve pain control, and potentially mitigate chronic post-surgical pain. Magnesium sulphate (MgSO4 ) is increasingly studied as an adjuvant in regional anesthesia, owing to its NMDA-receptor antagonism, calcium channel modulation, and possible anti-inflammatory effects. Meta-analyses in peripheral nerve blocks, such as supraclavicular brachial plexus block, have demonstrated that adding MgSO4 prolongs sensory and motor blockade, delays the need for rescue analgesia, and is generally well tolerated. Moreover, in abdominal surgery, MgSO4 added to bupivacaine in a transversus abdominis plane (TAP) block significantly reduced postoperative pain scores and extended analgesia duration. Erector spinae plane block is particularly attractive in mastectomy because it provides extensive dorsal and lateral thoracic analgesia. Beyond ESPB and Pectointercostal Plane Block, other interfascial plane blocks in breast surgery have also shown benefit with magnesium. Such consistent results across different block techniques support the hypothesis that magnesium enhances regional anesthesia outcomes in breast surgery.
Despite this promising data, there remain gap. No study has yet, concurrently evaluated magnesium as an adjuvant to both PIP block and ESPB in the same patient population, nor assessed its effects on both acute postoperative pain and the development of chronic postoperative pain.
So, the aim of this randomized controlled trial is to evaluate the safety and efficacy of adding magnesium sulphate to the combination of PIP block and ESPB for reducing acute and chronic post mastectomy pain in patients undergoing modified radical mastectomy.
A randomized controlled double-blinded study will be conducted in South Egypt Cancer Institute, Assiut University, after approval from the Institutional Ethics Committee.
Primary outcome:
Time to first rescue analgesia.
Secondary outcomes:
Total opioid consumption (morphine equivalent) in the first 24 hours postoperatively.
Postoperative pain scores (VAS) at rest and movement. Incidence of postoperative nausea and vomiting. Block-related complications. Incidence and severity of chronic post mastectomy pain.
- Conditions
- Post-mastectomy Pain Syndrome
- Being tested
- Pectointercostal Plane Block (PIPB), Erector Spinae Plane Block (ESPB), Magnesium sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pectointercostal Plane Block (PIPB)Procedure or surgery
Also called (PIPB)
A high-frequency linear ultrasound probe will be placed at the level of the 2nd-3rd rib, medial to the pectoralis major muscle. The pectointercostal fascial plane located between the pectoralis major muscle and the external/internal intercostal muscles will be identified. Under in plane ultrasound guidance, the needle will be advanced into this plane, and the study drug will be administered. All patients will receive 20 mL of 0.25% bupivacaine; however, patients in Group M will additionally receive magnesium sulphate 150 mg diluted to 5 mL, which will be injected into the same plane.
Erector Spinae Plane Block (ESPB)Procedure or surgery
Also called (ESPB):
For this block, the patient will be positioned laterally. The ultrasound probe will be placed at the T3-T5 vertebral level to visualize the transverse process. An in- plane technique will be used to advance the needle into the deep fascial plane beneath the erector spinae muscle. Once the correct position is confirmed, 20 mL of 0.25% bupivacaine will be injected, with Group M patients receiving an additional 150 mg of magnesium sulphate diluted to 5 mL. The total magnesium dose administered in Group M will be 300 mg. Negative aspiration will be performed prior to each injection to avoid intravascular administration.
Magnesium sulfateDrug
All patients will receive 20 mL of 0.25% bupivacaine; however, patients in Group M will additionally receive magnesium sulphate 150 mg diluted to 5 mL, which will be injected into the same plane. The total magnesium dose administered in Group M will be 300 mg
| Study group | Role | What they receive |
|---|---|---|
| Group M (Magnesium Group) | Active comparator | Patients will receive the combined PIP and ESP blocks using bupivacaine + magnesium sulphate.
* 20 mL of 0.25% bupivacaine + 150 mg magnesium sulphate diluted to5 ml (in each block).
* 150 mg with each block (total magnesium dose = 300 mg). Receives: Procedure: Pectointercostal Plane Block (PIPB); Procedure: Erector Spinae Plane Block (ESPB); Drug: Magnesium sulfate |
| Group C (Control Group) | Sham comparator | Patients will receive the combined PIP and ESP blocks using bupivacaine only (20 ml of 0.25% bupivacaine) Receives: Procedure: Pectointercostal Plane Block (PIPB); Procedure: Erector Spinae Plane Block (ESPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia.
Rescue analgesia of morphine will be given as 3 mg bolus if the VAS > 3 to be repeated after 30 min if pain persists until the VAS < 4.
Measured: 24 hours postoperatively
Secondary outcomes (2)
Total opioid consumption .
Total opioid consumption (morphine equivalent) in the first 24 hours postoperatively
Measured: 24 hours postoperatively
Postoperative pain scores (VAS)
Postoperative pain scores (VAS) at rest and movement where 0= no pain, 10= worst imaginable pain
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 posted27 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-mastectomy Pain SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An online randomization program (http://www.randomizer.org) will be used to generate a random list and each patient's code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner: Group M (Magnesium Group) (n=25): Patients will receive the combined PIP and ESP blocks using bupivacaine + magnesium sulphate. 20 mL of 0.25% bupivacaine + 150 mg magnesium sulphate diluted to 5 ml (in each block).(150 mg with each block (total magnesium dose = 300 mg). Group C (Control Group) (n=25): Patients will receive the combined PIP and ESP blocks using bupivacaine only (20 mL of 0.25% bupivacaine).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 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
- NCT07438366
- Sponsor's protocol ID
- 18-2026-811
- Other IDs
- 811
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 27 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Magnesium Sulphate to Combined Pectointercostal Plane Block and Erector Spinae Plane Block for Acute and Chronic Post-Mastectomy Pain After Modified Radical Mastectomy. A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07438366
- Acronym / sponsor ID
- 18-2026-811
- Conditions
- Post-mastectomy Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 27 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.
Given the burden of chronic postmastectomy pain and the need for effective, opioid-sparing analgesia, the propose of the randomized controlled trial is to evaluate the safety and efficacy of adding magnesium sulphate to the combination of PIP block and ESPB in patients undergoing modified radical mastectomy for reducing acute and chronic post mastectomy pain
Detailed description
Breast cancer remains one of the most common malignancies worldwide, and modified radical mastectomy (MRM) continues to be a mainstay surgical treatment in many cases. However, postoperative pain after MRM can be significant, both in the acute period and long-term, contributing to persistent pain syndromes, impaired recovery, and reduced quality of life. Regional anesthesia techniques such as the pectointercostal plane (PIPB) block and erector spinae plane block (ESPB) have gained wide acceptance as effective approaches to reduce perioperative analgesic requirements, improve pain control, and potentially mitigate chronic post-surgical pain. Magnesium sulphate (MgSO4 ) is increasingly studied as an adjuvant in regional anesthesia, owing to its NMDA-receptor antagonism, calcium channel modulation, and possible anti-inflammatory effects. Meta-analyses in peripheral nerve blocks, such as supraclavicular brachial plexus block, have demonstrated that adding MgSO4 prolongs sensory and motor blockade, delays the need for rescue analgesia, and is generally well tolerated. Moreover, in abdominal surgery, MgSO4 added to bupivacaine in a transversus abdominis plane (TAP) block significantly reduced postoperative pain scores and extended analgesia duration. Erector spinae plane block is particularly attractive in mastectomy because it provides extensive dorsal and lateral thoracic analgesia. Beyond ESPB and Pectointercostal Plane Block, other interfascial plane blocks in breast surgery have also shown benefit with magnesium. Such consistent results across different block techniques support the hypothesis that magnesium enhances regional anesthesia outcomes in breast surgery.
Despite this promising data, there remain gap. No study has yet, concurrently evaluated magnesium as an adjuvant to both PIP block and ESPB in the same patient population, nor assessed its effects on both acute postoperative pain and the development of chronic postoperative pain.
So, the aim of this randomized controlled trial is to evaluate the safety and efficacy of adding magnesium sulphate to the combination of PIP block and ESPB for reducing acute and chronic post mastectomy pain in patients undergoing modified radical mastectomy.
A randomized controlled double-blinded study will be conducted in South Egypt Cancer Institute, Assiut University, after approval from the Institutional Ethics Committee.
Primary outcome:
Time to first rescue analgesia.
Secondary outcomes:
Total opioid consumption (morphine equivalent) in the first 24 hours postoperatively.
Postoperative pain scores (VAS) at rest and movement. Incidence of postoperative nausea and vomiting. Block-related complications. Incidence and severity of chronic post mastectomy pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- An online randomization program (http://www.randomizer.org) will be used to generate a random list and each patient's code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner: Group M (Magnesium Group) (n=25): Patients will receive the combined PIP and ESP blocks using bupivacaine + magnesium sulphate. 20 mL of 0.25% bupivacaine + 150 mg magnesium sulphate diluted to 5 ml (in each block).(150 mg with each block (total magnesium dose = 300 mg). Group C (Control Group) (n=25): Patients will receive the combined PIP and ESP blocks using bupivacaine only (20 mL of 0.25% bupivacaine).
| Arm | Type | Receives |
|---|---|---|
| Group M (Magnesium Group) | Active comparator | Procedure: Pectointercostal Plane Block (PIPB), Procedure: Erector Spinae Plane Block (ESPB), Drug: Magnesium sulfatePatients will receive the combined PIP and ESP blocks using bupivacaine + magnesium sulphate. * 20 mL of 0.25% bupivacaine + 150 mg magnesium sulphate diluted to5 ml (in each block). * 150 mg with each block (total magnesium dose = 300 mg). |
| Group C (Control Group) | Sham comparator | Procedure: Pectointercostal Plane Block (PIPB), Procedure: Erector Spinae Plane Block (ESPB)Patients will receive the combined PIP and ESP blocks using bupivacaine only (20 ml of 0.25% bupivacaine) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients aged ≥18 years.
- American Society of Anesthesiologists (ASA) class I-III.
- Scheduled for unilateral modified radical mastectomy.
Key exclusion criteria (9 listed)
- Known allergy to local anesthetics or magnesium.
- Coagulopathy or anticoagulant therapy.
- Local infection at injection site.
- Body mass index (BMI) ≥ 40 kg/m2.
- Chronic opioid use or chronic pain disorders.
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 |
|---|---|---|
| Pectointercostal Plane Block (PIPB)Also: (PIPB)A high-frequency linear ultrasound probe will be placed at the level of the 2nd-3rd rib, medial to the pectoralis major muscle. The pectointercostal fascial plane located between the pectoralis major muscle and the external/internal intercostal muscles will be identified. Under in plane ultrasound guidance, the needle will be advanced into this plane, and the study drug will be administered. All patients will receive 20 mL of 0.25% bupivacaine; however, patients in Group M will additionally receive magnesium sulphate 150 mg diluted to 5 mL, which will be injected into the same plane. | Procedure or surgery | Group C (Control Group), Group M (Magnesium Group) |
| Erector Spinae Plane Block (ESPB)Also: (ESPB):For this block, the patient will be positioned laterally. The ultrasound probe will be placed at the T3-T5 vertebral level to visualize the transverse process. An in- plane technique will be used to advance the needle into the deep fascial plane beneath the erector spinae muscle. Once the correct position is confirmed, 20 mL of 0.25% bupivacaine will be injected, with Group M patients receiving an additional 150 mg of magnesium sulphate diluted to 5 mL. The total magnesium dose administered in Group M will be 300 mg. Negative aspiration will be performed prior to each injection to avoid intravascular administration. | Procedure or surgery | Group C (Control Group), Group M (Magnesium Group) |
| Magnesium sulfateAll patients will receive 20 mL of 0.25% bupivacaine; however, patients in Group M will additionally receive magnesium sulphate 150 mg diluted to 5 mL, which will be injected into the same plane. The total magnesium dose administered in Group M will be 300 mg | Drug | Group M (Magnesium Group) |
Primary outcome
Time to first rescue analgesia.
Time frame: 24 hours postoperatively
Rescue analgesia of morphine will be given as 3 mg bolus if the VAS > 3 to be repeated after 30 min if pain persists until the VAS < 4.
2 secondary outcomes
Total opioid consumption .
Time frame: 24 hours postoperatively
Postoperative pain scores (VAS)
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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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 Pectointercostal Plane Block (PIPB), Erector Spinae Plane Block (ESPB) and Magnesium sulfate in people with Post-mastectomy Pain Syndrome, 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 9 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 27 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, lecturer (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?
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 27 Feb 2026.