Analgesic Effect of Serratus Plane Block With Adjuvant Agents in Breast Cancer Surgery
- Conditions
- Breast CancerPost Operative Pain
- Interventions
- Drug: Bupivacaine and Magnesium sulfateDrug: Bupivacaine and Dexmedetomidine ile Blokaj
- Registration Number
- NCT07081581
- Lead Sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 30-70 years old, ASA I-II-III patient group,
- Not hypersensitive to the drugs to be used in the study or to the substances contained in them,
- No infection or anatomical deformation at the site of intervention,
- No antithrombotic treatment and normal coagulation parameters,
- Patients who have the consent of themselves or one of their legal guardians.
- Less than 30 years of age, older than 70 years of age or ASA (American Society of Anaesthesiologists) Classification IV,
- Receiving antithrombotic therapy with abnormal coagulation parameters,
- Infection or anatomical abnormality at the blockage site,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B Bupivacain Group B (Blockade with Bupivacaine): 30 mL bupivacaine (0.25%) Group M Bupivacaine and Magnesium sulfate Group M (Bupivacaine+Magnesium Blockade): 30 mL bupivacaine (0.25%) + 500 mg magnesium sulphate Group D Bupivacaine and Dexmedetomidine ile Blokaj Group D (bupivacaine + dexmedetomidine ile Blokaj): 30 mL bupivacaine (% 0.25) + 1 μg/kg dexmedetomidine.
- Primary Outcome Measures
Name Time Method Postoperative analgesic efficacy until the 24th hour postoperatively 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.
- Secondary Outcome Measures
Name Time Method Complications due to adjuvant agents until the 24th hour postoperatively Complications due to adjuvant agents used in serratus plan blockade
Trial Locations
- Locations (1)
Sultan 2. Abdulhamid Han Training and Research Hospital
🇹🇷İstanbul, Üsküdar, Turkey
Sultan 2. Abdulhamid Han Training and Research Hospital🇹🇷İstanbul, Üsküdar, Turkey