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IRCT20181126041760N1 IRCT 2019-07-23 Shahid Beheshti University of Medical Sciences comparison the effect of Erector Spinae Block VS Pectoral 1 Block on post operative pain , nausea and vomiting in breast mass surgeries ; a double blind randomized study comparison the effect of Erector Spinae Block VS Pectoral 1 Block on post operative pain , nausea and vomiting in breast mass surgeries ; a double blind randomized study 2019-05-08 anticipated 64 Complete https://irct.ir/trial/39783 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Related code was given to all patients by Computer based on Random number table and the patients were divided in two groups (simple randomization) . In one group the second anesthesiologist who wasn't aware from research type, blocked the patients based on closed envelope which include the type of block. The main researcher was not aware about the block was used for each patient, Blinding description: Patients and the anesthesiology resident were not aware about type of blocks. although the patient was aware and consent about Nerve block benefits, anesthesiologist who did the block was not participated in complition of questioner. 3 Analgesia in chest wall operations. Intervention 1: Intervention group: pecs1 block/ after consent for regional block , qualified person put in table of random numbers.before general anesthesia in aseptic field on sonography guide we did pecs1 block(20cc rupivacaine .25%).patients received drugs for general anesthesia.BIS was monitored(40-60).after surgery in full awake patients we measured pain(VAS score),nausa,need for narcotic,vomiting. Intervention 2: Intervention group:erector soinae block/ after consent for regional block , qualified person put in table of random numbers.before general anesthesia in aseptic field on sonography guide we did erector spinae block (20cc rupivacaine .25%).patients received drugs for general anesthesia.BIS was monitored(40-60).after surgery in full awake patients we measured pain(VAS score),nausa,need for narcotic,vomiting. Yes - There is a plan to make this available What will be shared: all data will be published without identifying personal identities. When: almost 6 months after result publication To whom: َll persons Conditions: After contacting with corresponding author, dr.Houman Teymourian Where to obtain: Houman Teymourian How to obtain: 1 week after contacting with corresponding author Houman Teymourian Comments:
public Houman Teymourian
Anesthesia department, Shohada Tajrish hospital, Shahrdari street, Tajrish squer, Tehran, Iran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 1174 houman72625@yahoo.com Shahid Beheshti University of Medical Sciences scientific Houman Teymourian
tajrish square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 1174 dr.teymourian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) women age 18-50 ASA class 1-2 insensitivity to LA No psychotic disorder No addiction no hemostasis disorder no local skin infection no use analgesic and NSAID drugs 18 years 50 years Female operation time more than 4 hours excessive blood loss changing procidure type N60 benign mammary dysplasia skin of breast Other Other Intervention group: pecs1 block/ after consent for regional block , qualified person put in table of random numbers.before general anesthesia in aseptic field on sonography guide we did pecs1 block(20cc rupivacaine .25%).patients received drugs for general anesthesia.BIS was monitored(40-60).after surgery in full awake patients we measured pain(VAS score),nausa,need for narcotic,vomiting. Intervention group:erector soinae block/ after consent for regional block , qualified person put in table of random numbers.before general anesthesia in aseptic field on sonography guide we did erector spinae block (20cc rupivacaine .25%).patients received drugs for general anesthesia.BIS was monitored(40-60).after surgery in full awake patients we measured pain(VAS score),nausa,need for narcotic,vomiting. PAIN. Timepoint: recovery/60minutes after recovery/2hours after recovery/4hours after recovery/6hours after recovery. Method of measurement: visual analogue scale. Nausea. Timepoint: recovery/60minutes after recovery/2hours after recovery/4hours after recovery/6hours after recovery. Method of measurement: questionnaire. Vomiting. Timepoint: recovery/60minutes after recovery/2hours after recovery/4hours after recovery/6hours after recovery. Method of measurement: questionnaire. Blood Pressure. Timepoint: after injection/15minutes after/30minutes after/45minutes after/60minutes after/75minutes after/90minutes after/2hours after/3hours after/4hours after/6hours after. Method of measurement: BP monitoring (mmhg). Herat rate. Timepoint: after injection/15minutes after/30minutes after/45minutes after/60minutes after/75minutes after/90minutes after/2hours after/3hours after/4hours after/6hours after. Method of measurement: HR monitoring. Need for narcotic. Timepoint: Recovery/60 minutes after recovery/2 hours after recovery/4 hours after recovery/6 hours after recovery. Method of measurement: patient file (macrogram). Shahid Beheshti University of Medical Sciences Approved 2019-05-08 ethics research of shahid beheshti university of medical sciense ERABI STREET tehran Tehran Iran (Islamic Republic of)