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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorSouth Egypt Cancer Institute

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged ≥18 years.

American Society of Anesthesiologists (ASA) class I-III.

Scheduled for unilateral modified radical mastectomy.

Disqualifiers

Known allergy to local anesthetics or magnesium.

Coagulopathy or anticoagulant therapy.

Local infection at injection site.

Body mass index (BMI) ≥ 40 kg/m2.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pectointercostal Plane Block (PIPB)

    Procedure/Surgery

    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/Surgery

    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 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group M (Magnesium Group)Active comparator 3 interventions
Group B: Group C (Control Group)Sham comparator 2 interventions

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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South Egypt Cancer Institute

Lead sponsor

Assiut University

Collaborator

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