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
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
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.
Exclusion Criteria:
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
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)
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)
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
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
Total opioid consumption .
Total opioid consumption (morphine equivalent) in the first 24 hours postoperatively
Time frame: 24 hours postoperatively
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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South Egypt Cancer Institute