Adding Magnesium Sulphate to Combined Pectointercostal Plane and Erector Spinae Plane Blocks for Acute and Chronic Post-Mastectomy Pain
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
2 other identifiers
interventional
60
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2026
CompletedStudy Start
First participant enrolled
February 15, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 15, 2027
February 27, 2026
February 1, 2026
9 months
February 8, 2026
February 22, 2026
Conditions
Outcome Measures
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.
24 hours postoperatively
Secondary Outcomes (2)
Total opioid consumption .
24 hours postoperatively
Postoperative pain scores (VAS)
24 hours postoperatively
Study Arms (2)
Group M (Magnesium Group)
ACTIVE COMPARATORPatients 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 COMPARATORPatients will receive the combined PIP and ESP blocks using bupivacaine only (20 ml of 0.25% bupivacaine)
Interventions
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.
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.
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
Eligibility Criteria
You may qualify if:
- Female patients aged ≥18 years.
- American Society of Anesthesiologists (ASA) class I-III.
- Scheduled for unilateral modified radical mastectomy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- South Egypt Cancer Institutelead
- Assiut Universitycollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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:Patients and outcome assessors will be blinded to the study groups.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of anesthesia
Study Record Dates
First Submitted
February 8, 2026
First Posted
February 27, 2026
Study Start
February 15, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
February 15, 2027
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share