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
27. august 2026 opdateret af: King Hussein Cancer Center
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
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
70
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Supervisor, Clinical Trials Unit
- Telefonnummer: 1342 +962 6 5300460
- E-mail: FZahran@KHCC.JO
Undersøgelse Kontakt Backup
- Navn: Clinical Research Coordinator
- Telefonnummer: +962 788390734
- E-mail: aa.18586@KHCC.JO
Studiesteder
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Amman, Jordan
- King Hussien Cancer Centre
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Kontakt:
- Supervisor, Clinical Trials Unit
- Telefonnummer: 1342 +962 6 5300460
- E-mail: FZahran@KHCC.JO
-
Kontakt:
- Clinical Research Coordinator, 0.22
- Telefonnummer: 1342 +962 788390734
- E-mail: aa.18586@KHCC.JO
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Magnesium Sulfate + Bupivacaine
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.
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Magnesium sulfate 750 mg added to 0.5% bupivacaine for a single intraoperative local wound infiltration following modified radical mastectomy with axillary clearance.
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Aktiv komparator: Bupivacaine + Normal Saline
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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Overall Postoperative Pain Burden During the First 24 Hours After Surgery
Tidsramme: From the end of surgery through 24 hours postoperatively.
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Area under the curve (AUC) of Visual Analogue Scale (VAS) pain scores at rest during the first 24 hours after surgery.
The Visual Analogue Scale (VAS) ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain.
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From the end of surgery through 24 hours postoperatively.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- Antel R, Ingelmo P. Local anesthetic systemic toxicity. CMAJ. 2022 Sep 26;194(37):E1288. doi: 10.1503/cmaj.220835. No abstract available.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. december 2027
Studieafslutning (Anslået)
1. marts 2028
Datoer for studieregistrering
Først indsendt
24. august 2026
Først indsendt, der opfyldte QC-kriterier
24. august 2026
Først opslået (Faktiske)
27. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 25 KHCC 159
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