A Double-Blind, Randomized Controlled 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

NCT07789600 | Not Yet Recruiting

• 1 other identifier: 25 KHCC 159
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Modified Radical Mastectomy

Outcome Measures

Primary Outcomes (1)

• Overall Postoperative Pain Burden During the First 24 Hours After Surgery

  Area under the curve (AUC) of Visual Analogue Scale (VAS) pain scores at rest during the first 24 hours after surgery.

  From the end of surgery through 24 hours postoperatively.

Study Arms (2)

Magnesium Sulfate + Bupivacaine

EXPERIMENTAL

Participants will receive a single intraoperative local wound infiltration following modified radical mastectomy with axillary clearance, consisting of 750 mg magnesium sulfate combined with 0.5% bupivacaine. The planned bupivacaine dose is 100 mg (20 mL), subject to reduction if it exceeds the participant-specific maximum allowable dose based on body weight.

Drug: Magnesium Sulfate 750 mg with Bupivacaine 0.5% for Local Wound Infiltration

Bupivacaine + Normal Saline

ACTIVE COMPARATOR

Participants will receive a single intraoperative local wound infiltration following modified radical mastectomy with axillary clearance, consisting of 0.5% bupivacaine combined with normal saline. The planned bupivacaine dose is 100 mg (20 mL), subject to reduction if it exceeds the participant-specific maximum allowable dose based on body weight.

Drug: Bupivacaine 0.5% + Normal Saline

Interventions

Magnesium Sulfate 750 mg with Bupivacaine 0.5% for Local Wound Infiltration DRUG

Magnesium sulfate 750 mg added to 0.5% bupivacaine for a single intraoperative local wound infiltration following modified radical mastectomy with axillary clearance.

Magnesium Sulfate + Bupivacaine

Bupivacaine 0.5% + Normal Saline DRUG

A single intraoperative local wound infiltration of 0.5% bupivacaine combined with normal saline following modified radical mastectomy with axillary clearance. The planned bupivacaine dose is 100 mg (20 mL), subject to reduction if it exceeds the participant-specific maximum allowable dose based on body weight.

Bupivacaine + Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult female patients (age ≥18 years) undergoing elective modified radical mastectomy (MRM) with axillary clearance.
• ASA physical status I-III.
• Willingness to participate and provide informed consent.

You may not qualify if:

• Allergy to bupivacaine or magnesium.
• Chronic opioid use or pre-existing chronic pain conditions.
• Significant renal or hepatic impairment.
• Pregnancy or lactation.
• Neuromuscular disorders.
• Abnormal baseline serum magnesium levels (e.g., hypermagnesemia).

Sponsors & Collaborators

• King Hussein Cancer Center: lead

Study Sites (1)

King Hussien Cancer Centre

Amman, Jordan

Location

Related Publications (10)

• Antel R, Ingelmo P. Local anesthetic systemic toxicity. CMAJ. 2022 Sep 26;194(37):E1288. doi: 10.1503/cmaj.220835. No abstract available.

  PMID: 36162843 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.

  PMID: 15635516 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.

  PMID: 34682777 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.

  PMID: 23121612 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.

  PMID: 25885979 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.

  PMID: 19226292 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.

  PMID: 36447918 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.

  PMID: 27190924 BACKGROUND

MeSH Terms

Interventions

Magnesium Sulfate; Bupivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Supervisor, Clinical Trials Unit

CONTACT

+962 6 5300460; FZahran@KHCC.JO

Clinical Research Coordinator

CONTACT

+962 788390734; aa.18586@KHCC.JO

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

JO (1)