Trial Evaluating the Analgesic Efficacy of Magnesium Sulfate as an Adjuvant to Bupivacaine in Local Wound Infiltration for Patients Undergoing Modified Radical Mastectomy (MRM) With Axillary Clearance

Summary

This is a double-blind, randomized, controlled clinical trial evaluating the analgesic efficacy and safety of magnesium sulfate as an adjuvant to bupivacaine for local wound infiltration in patients undergoing modified radical mastectomy with axillary clearance. Participants will be randomized to receive either magnesium sulfate 750 mg with bupivacaine or the control intervention. Postoperative pain, analgesic requirements, and safety outcomes will be assessed during the postoperative period, including a follow-up safety assessment between Day 7 and Day 14 after surgery.

Timeline

Start

2026-09-01

Primary completion

2027-12-01

Completion

2028-03-01

Publications

• Background Antel R, Ingelmo P. Local anesthetic systemic toxicity. CMAJ. 2022 Sep 26;194(37):E1288. doi: 10.1503/cmaj.220835. No abstract available.
• Background Rosenberg PH, Veering BT, Urmey WF. Maximum recommended doses of local anesthetics: a multifactorial concept. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):564-75; discussion 524. doi: 10.1016/j.rapm.2004.08.003.
• Background Stamenkovic DM, Bezmarevic M, Bojic S, Unic-Stojanovic D, Stojkovic D, Slavkovic DZ, Bancevic V, Maric N, Karanikolas M. Updates on Wound Infiltration Use for Postoperative Pain Management: A Narrative Review. J Clin Med. 2021 Oct 11;10(20):4659. doi: 10.3390/jcm10204659.
• Background Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1.
• Background Eldaba AA, Amr YM, Sobhy RA. Effect of wound infiltration with bupivacaine or lower dose bupivacaine/magnesium versus placebo for postoperative analgesia after cesarean section. Anesth Essays Res. 2013 Sep-Dec;7(3):336-40. doi: 10.4103/0259-1162.123227.
• Background 5. Dabbagh A, Elyasi H, Fathololoumi S, Fathi M. Magnesium sulfate infiltration of pectoralis major muscle for analgesia after mastectomy: A randomized controlled trial. Regional Anesthesia and Pain Medicine. 2021;46(8):655-661.
• Background 4. Alshawadfy A, Abdel-Ghaffar M, Magdy N. Comparative analgesic efficacy of adding magnesium sulphate to bupivacaine in serratus anterior plane block to reduce pain after mastectomy. Southern African Journal of Anaesthesia and Analgesia. 2022;28(6):235-240. doi:10.36303/SAJAA.2022.28.6.2783
• Background Tauzin-Fin P, Sesay M, Svartz L, Krol-Houdek MC, Maurette P. Wound infiltration with magnesium sulphate and ropivacaine mixture reduces postoperative tramadol requirements after radical prostatectomy. Acta Anaesthesiol Scand. 2009 Apr;53(4):464-9. doi: 10.1111/j.1399-6576.2008.01888.x. Epub 2009 Feb 18.
• Background Dave S, Gopalakrishnan K, Krishnan S, Natarajan N. Analgesic Efficacy of Addition of Magnesium Sulfate to Bupivacaine in Wound Infiltration Technique in Perianal Surgeries. Anesth Essays Res. 2022 Apr-Jun;16(2):250-254. doi: 10.4103/aer.aer_107_22. Epub 2022 Oct 7.
• Background Kundra S, Singh RM, Singh G, Singh T, Jarewal V, Katyal S. Efficacy of Magnesium Sulphate as an Adjunct to Ropivacaine in Local Infiltration for Postoperative Pain Following Lower Segment Caesarean Section. J Clin Diagn Res. 2016 Apr;10(4):UC18-22. doi: 10.7860/JCDR/2016/17119.7683. Epub 2016 Apr 1.

Drugs

Indications

No indication recorded.