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NCT Number: NCT07438366

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Severe hepatic or renal impairment.
  • Pregnancy.
  • Lactation.

Treatment and study plan

Pectointercostal Plane Block (PIPB)

Procedure

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.

Other names: (PIPB)

Erector spinae plane block (ESPB)

Procedure

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.

Other names: (ESPB):

Magnesium sulfate

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total opioid consumption .

    Time frame: 24 hours postoperatively

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

  2. Postoperative pain scores (VAS)

    Time frame: 24 hours postoperatively

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

Study contacts

Contact information is provided by the study sponsor or research team.

bahaa ga saad, lecturer

CONTACT

01003644592

mohamed fa abd elhamed, lecturer

CONTACT

[email protected]

01015249890 ext. 02

Sponsors and collaborators

Lead sponsor

South Egypt Cancer Institute

Other

Collaborators

  • Assiut University

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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