ClinicalTrials.gg
Not yet recruitingNCT07438366Updated Feb 27, 2026

Adding Magnesium Sulphate to Combined Pectointercostal Plane and Erector Spinae Plane Blocks for Acute and Chronic Post-Mastectomy Pain

An interventional study of Pectointercostal Plane Block (PIPB) and Erector Spinae Plane Block (ESPB) in Post-mastectomy Pain Syndrome, sponsored by South Egypt Cancer Institute. Not yet recruiting. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by South Egypt Cancer Institute · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies testing Magnesium Sulfate in Pain — 4 open to participants now, 4 under way, 1 of them phase 3. Magnesium Sulfate · Pain.

Planned enrollment
11th of 19
60 · median 70
Started
2026
the only one that year
No phase
7 of 19
1 open now
Registered
18th of 19
by date

Among the 19 studies testing Magnesium Sulfate in Pain, this one is the 11th largest by planned enrollment, is the only one that started in 2026, is one of 7 with no phase, and was the 18th registered.

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

Browse Pain studies →

Open to participants now

4 of the 19 studies testing Magnesium Sulfate in Pain are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

About Magnesium Sulfate

Magnesium Sulfate: first FDA approval 1981 (TIS-U-SOL IN PLASTIC CONTAINER). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.

This study: 18 Years to 65 Years · female · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Post-mastectomy Pain Syndrome

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04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female patients aged ≥18 years.
  • (ASA) class I-III.
  • Scheduled for unilateral modified radical mastectomy.

Exclusion criteria

Exclusion Criteria:

  • Known allergy to local anesthetics or magnesium.
  • Coagulopathy or anticoagulant therapy.
  • Local infection at injection site.
  • (BMI) ≥ 40 kg/m2.
  • Chronic opioid use or chronic pain disorders.
  • Neurological or psychiatric disorders affect pain perception.
  • Severe hepatic or renal impairment.
  • Pregnancy.
  • Lactation.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Group M (Magnesium Group)

    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).

    Procedure: Pectointercostal Plane Block (PIPB) · Procedure: Erector Spinae Plane Block (ESPB) · Drug: Magnesium sulfate

  • Sham comparator
    Group C (Control Group)

    Patients will receive the combined PIP and ESP blocks using bupivacaine only (20 ml of 0.25% bupivacaine)

    Procedure: Pectointercostal Plane Block (PIPB) · Procedure: Erector Spinae Plane Block (ESPB)

Interventions

  • ProcedurePectointercostal Plane Block (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.

    Also known as: (PIPB)

  • ProcedureErector Spinae Plane Block (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.

    Also known as: (ESPB):

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Total opioid consumption .

    Total opioid consumption (morphine equivalent) in the first 24 hours postoperatively

    Time frame: 24 hours postoperatively

  2. Postoperative pain scores (VAS)

    Postoperative pain scores (VAS) at rest and movement where 0= no pain, 10= worst imaginable pain

    Time frame: 24 hours postoperatively

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2026; primary completion for Nov 2026, 8 months later.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 8 months is below that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 8, 2026
First posted
Feb 27, 2026
StartEst.
Feb 15, 2026
Primary completionEst.
Nov 1, 2026
CompletionEst.
Feb 15, 2027
Last update
Feb 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07438366
Lead sponsor
South Egypt Cancer Institute
Collaborators
Assiut University
Responsible party
Mohammed Farghaly Abd El hamid Ahmed (lecturer of anesthesia, South Egypt Cancer Institute) — Principal investigator
First posted
Feb 27, 2026
Start date
Feb 15, 2026 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
Feb 15, 2027 (estimated)
Last update
Feb 27, 2026

Study contacts

mohamed fa abd elhamed, lecturer
Contact
m.farghaly.na@gmail.com
01015249890 ext. 02
bahaa ga saad, lecturer
Contact
01003644592

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Magnesium Sulfate

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