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IRCT20220212054002N1 IRCT 2022-03-18 Mansoura university calcitonin in mastectomy pain analgesic effect of adding calcitonin to bupivacaine in erector spine plane block for breast surgery ,double blind randomized study 2021-04-01 anticipated 130 Complete https://irct.ir/trial/61885 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients will randomly allocated to control group (A) and study group (B) with allocated ratio 1:1 .Randomization will done before surgery by computer generated random ,Version28.0 . Opaque sealed sequentially numbered envelopes containing the patients` codes will used and opened just before anethesia by physician who will not involved in the study A pharmacist will prepare the drug mixture. The patients will be allocated to either control group— group “A”, who receive only bupivacaine , or study group— group “B” who receive calcitonin plus bupivacaine in the ESP block with general anesthesia, Blinding description: participant ,care givers ,investigators all are blind to component of solution injected in unilateral erector spine plane block ,under ultrasound after general anesthesia .As solution will be prepared by anesthesia technician in medication room before patient enter the operation room according to allocated randomized number . 4 acute post mastectomy pain and post operative inflammatory reaction. Intervention 1: control group: ultrasound guided unilateral erector spine plane block will be performed under complete aseptic condition after induction of general anesthesia directly and 15 min before skin incision with 100mm 21 G needle while the patient in unilateral position ,60 patient in the group solution used for injection will be (30 ml bupivacaine 0.25% plus 2ml saline ). Intervention 2: Intervention group: ultrasound guided unilateral erector spine plane block will be performed under complete aseptic condition after induction of general anesthesia directly and 15 min before skin incision with 100mm 21 G needle while the patient in unilateral position ,60 patient in the group solution used for injection will be (30 ml bupivacaine 0.25% plus 50 IU calcitonin in 2ml saline ). Yes - There is a plan to make this available What will be shared: IPD collected for primary outcome When: available starting 6 month after publication To whom: people working in academic institutions Conditions: academic purpose Where to obtain: email address// zenatddd@gmail .com How to obtain: email address Comments:
public Zenat Eldadamony Mohamed
Algomhorria
Mansoura Egypt 35516 +20 122 543 9066 zenatddd@gmail.com Mansoura University Hospital scientific Zenat Eldadamony Mohamed
Algomhorria
Mansoura Egypt 35516 +20 122 543 9066 zenatddd@gmail.com Mansoura University Egypt Female patients Aged 18–65 years, American Society of Anesthesiologists physical status I and II, Undergoing unilateral breast cancer surgery (modified radical mastectomy, breast conservational surgery, simple mastectomy and axillary clearance) 18 years 70 years Female patient refusal, history of bronchial asthma spinal deformities, coagulation disorders, allergy to local anesthetics, history of opioid usage for chronic pain cognitive/psychiatric disorders infection at the injection site G89.18 Other acute postprocedural pain Treatment - Drugs Treatment - Drugs control group: ultrasound guided unilateral erector spine plane block will be performed under complete aseptic condition after induction of general anesthesia directly and 15 min before skin incision with 100mm 21 G needle while the patient in unilateral position ,60 patient in the group solution used for injection will be (30 ml bupivacaine 0.25% plus 2ml saline ) Intervention group: ultrasound guided unilateral erector spine plane block will be performed under complete aseptic condition after induction of general anesthesia directly and 15 min before skin incision with 100mm 21 G needle while the patient in unilateral position ,60 patient in the group solution used for injection will be (30 ml bupivacaine 0.25% plus 50 IU calcitonin in 2ml saline ) Time to rescue analgesia (opioid) in post operative period. Timepoint: time point measured from the end of surgery to request of analgesic. Method of measurement: visual analogue scale to measure pain assessment of pain if VAS is more than 3 patient will receive morphine 10 Mg intramuscular and reassess after 30 min for pain relieve . Total opioid requirement. Timepoint: 24 hour post operative. Method of measurement: amount of drug prescribed amount of morphine consumption in Mg in 24 hour after the end of surgery. Inflammatory mediators (interleukin 6,interlokin 10, and tumor necrotic factor. Timepoint: before intervention and 2hour post operative ,12 hour post operative , and 24 hour post operative. Method of measurement: lab kit to measure inflammatory mediators. Mansoura university Approved 2022-01-29 Institutional Research Board ,IRB Algomhorria street Mansoura Dakahalia Egypt