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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Pectointercostal Plane Block (PIPB)
Procedure/SurgeryA 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/SurgeryFor 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
DrugAll 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Total opioid consumption .
Total opioid consumption (morphine equivalent) in the first 24 hours postoperatively
Postoperative pain scores (VAS)
Postoperative pain scores (VAS) at rest and movement where 0= no pain, 10= worst imaginable pain
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
South Egypt Cancer Institute
Lead sponsor
Assiut University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: