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IRCT20230219057451N2 IRCT 2023-08-09 DIponegoro University of Medical Sciences Peripheral Nerve Block of Serratus Anterior Plane As Analgesia After Modified Radical Mastectomy Surgery Block of Serratus Anterior Plane As Postoperative Analgesia of Modified Radical Mastectomy 2021-08-02 anticipated 40 Complete https://irct.ir/trial/71858 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization that we used was simple random sampling procedure. The randomization process was performed using numbers randomized by an internet-based computer program (www.randomization.com). The numbers were placed in a sealed envelope. The sealed envelope was opened when the patient arrived at the pre-operation room; then, the patient asked to take one of the papers containing a number. The intervention was given to the subjects selected through randomization based on number in the sealed envelope. Odd numbers were the intervention group, even numbers were the control group, Blinding description: This was double blind clinical trial. The patients who reported their Numeric Rating Scales (NRS) Pain Score scores were blinded to the group assignment because the patient did not know whether they were the control group or the intervention group. The Serratus Anterior Plane Block was performed when patient still unconscious under General Anesthesia. The Investigator and Outcome assessors also blinded to group assignment because NRS pain score assessed after the surgery inthe inpatient ward. So, the outcome assessor and investigator didn’t know which one is the intervention group or control group. 2-3 Breast Cancer Patient underwent Radical Mastectomy Surgery. Intervention 1: Intervention Group : The treatment group were induced with anesthesia drugs propofol 2 mg/kg BW, rocuronium 0.6 mg/kg BW and were given maintenance with sevoflurane 1 MAC, intravenous paracetamol 1000 mg, and ketorolac intravenously 30 mg. Then were given SAP block using isobaric bupivacaine 0.25% with 20 cc volume. Intervention 2: Control group: The control group were induced with anesthesia drugs propofol 2 mg/kg BW, rocuronium 0.6 mg/kg BW and were given maintenance with sevoflurane 1 MAC, intravenous paracetamol 1000 mg, and ketorolac intravenously 30 mg. Then were given morphine 20mcg/kg/h continuous infusion as analgesic. Yes - There is a plan to make this available What will be shared: Block of serratus anterior plane as postoperative analgesia of modified radical mastectomy When: 3 months after publication To whom: for people working in academic institutions or people working in businesses can also apply to receive it Conditions: as long as they asked permission to the author of this research Where to obtain: they could obtain by contacting us via email How to obtain: first they must ask permission via email then they made us formal letter to use this data Comments:
public Taufan Pramadika
No 32, Mintojiwo Dalam 3
Semarang Indonesia 50149 +62 24 7611196 taufanpramadika@gmail.com Diponegoro University scientific Mochamat, Mochamat
No. 15, Mintojiwo Timur
Semarang Indonesia 50149 +62 24 7605524 dr.mochamat@gmail.com Diponegoro University of Medical Sciences Indonesia patients who underwent MRM Age 18-59 years old Patient with American Society of Anesthesiologist (ASA) class I or II The patient can also speak verbally and use Numerical Rating Scales (NRS). 18 years 59 years Female Patients with opioid allergies were excluded from this study Patient is known to be taking drugs that are not the research protocol C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs Intervention Group : The treatment group were induced with anesthesia drugs propofol 2 mg/kg BW, rocuronium 0.6 mg/kg BW and were given maintenance with sevoflurane 1 MAC, intravenous paracetamol 1000 mg, and ketorolac intravenously 30 mg. Then were given SAP block using isobaric bupivacaine 0.25% with 20 cc volume Control group: The control group were induced with anesthesia drugs propofol 2 mg/kg BW, rocuronium 0.6 mg/kg BW and were given maintenance with sevoflurane 1 MAC, intravenous paracetamol 1000 mg, and ketorolac intravenously 30 mg. Then were given morphine 20mcg/kg/h continuous infusion as analgesic Numeric Rating Scale Pain Score. Timepoint: 4 hours, 8 hours, 12 hours, 24 hours after surgery. Method of measurement: Numeric Rating Scale. DIponegoro University of Medical Sciences Approved 2021-06-23 Health Research Ethic Committee RSUP DR. KARIADI SEMARANG No 16, DR Sutomo Street Semarang Central Java Indonesia