A Phase 2 interventional study of Bupivacain and Bupivacaine and Magnesium sulfate in Breast Cancer and Post Operative Pain, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Completed at 1 site in Turkey (Türkiye). Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Phase 2, Interventional, and Treatment
Pain after breast surgery has been described as moderate to severe in intensity and, if inadequately treated, increases postoperative morbidity, hospital cost, and the incidence of persistent postoperative pain. Serratus anterior plane block is an interfascial injection technique for analgesia of the chest wall. The aim of this study was to investigate the effect of magnesium and dexmedetomidine as adjuvant agents on postoperative analgesia in serratus anterior plane block in patients undergoing modified radical mastectomy.
In this prospective, double-blind, randomised controlled study, a total of 75 patients aged 30-70 years, who were planned for elective modified radical mastectomy after ethics committee approval, were included. Patients were randomly divided into three groups. After induction of general anaesthesia, serratus anterior plane block was applied to all patients. Group B received bupivacaine 30 ml (0.25%), Group D received bupivacaine 30 ml (0.25%) + dexmedetomidine 1μg/kg, Group M received bupivacaine 30 ml (0.25%) + 500 mg magnesium sulphate. Haemodynamic parameters, numerical rating scale (NRS) scores, number of tramadol use with patient-controlled analgesia device, additional analgesic drug consumption and side effects were recorded at 2, 6, 12 and 24 hours postoperatively.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 75 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 104 studies on the registry; 28 are open to participants now.
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Inclusion Criteria: - 30-70 years old, ASA I-II-III patient group,
Exclusion Criteria:
Group B (Blockade with Bupivacaine): 30 mL bupivacaine (0.25%)
Drug: Bupivacain
Group M (Bupivacaine+Magnesium Blockade): 30 mL bupivacaine (0.25%) + 500 mg magnesium sulphate
Drug: Bupivacaine and Magnesium sulfate
Group D (bupivacaine + dexmedetomidine ile Blokaj): 30 mL bupivacaine (% 0.25) + 1 μg/kg dexmedetomidine.
Drug: Bupivacaine and Dexmedetomidine ile Blokaj
In Group B( control group), bupivacaine was given as additional medication in the serratus block application.
Also known as: Control group
In Group M, bupivacaine and magnesium were given as additional medication in the serratus block application.
Also known as: Local anesthetic with added adjuvant agent(1)
In Group D, bupivacaine and dexmedetomidine were given as additional medication in the serratus block application.
Also known as: Local anesthetic with added adjuvant agent(2)
Postoperative analgesic efficacy
Hemodynamic parameters (heart rate, noninvasive mean arterial blood pressure, peripheral oxygen saturation), numerical rating scale (NRS) scores, number of tramadol uses with patient-controlled analgesia device, and additional analgesic drug consumption were recorded at 2, 6, 12, and 24 hours after surgery. The Numerical Rating Scale (NRS) is a subjective scale in which patients rate their pain intensity by selecting a number between 0 and 10. 0 means "no pain," while 10 means "worst pain imaginable." Patients typically rate their pain over the past 24 hours. It can be used in both verbal and written formats.
Time frame: until the 24th hour postoperatively
Complications due to adjuvant agents
Complications due to adjuvant agents used in serratus plan blockade
Time frame: until the 24th hour postoperatively
Plan to share: No
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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey