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IRCT20200421047160N1 IRCT 2020-05-20 Tehran University of Medical Sciences Effect of Lidocain and Epinephrin in Episiotomy Comparison of the Effect of Lidocaine Injection with / without Epinephrine on Pain and Hemorrhage after Episiotomy in Primigravida Women 2017-01-29 anticipated 220 Complete https://irct.ir/trial/47497 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, continuous sampling and allocation of samples in the two groups studied will be simple random and individuals with entry criteria will be in one of groups A or B, which are intervention and control groups. In this way, even and odd numbers will be written on the cards separately and the cards will be randomly selected by pregnant women. If the card is odd, the sample will be in group A and if it is even, it will be in group B. This method will continue until the sample size reaches 220 people, Blinding description: In this study, two groups will be blinded: participants and the main researcher Participants will enter the study after obtaining written consent, but will be randomly assigned to the intervention or control group and will not be aware of the type of anesthetic. The main researcher will also be unaware of the type of anesthesia used and will only be aware of the cause of the birth and the clinical caregiver who is the midwife of the delivery room, and will evaluate the outcome and collect the relevant data. 3 Episiotomy repair. Intervention 1: Intervention group: injection of lidocaine hydrochloride 2% from Caspian company in the amount of 2 ampoules of 5 mg per 100 cc with epinephrine from 1: 200,000 and 10cc syringes will be used for all injections. Two minutes after the anesthetic injection, the patient's pain will be assessed by a visual analog scale, which, if the patient complains of pain, will be re-injected at half the previous dose. Intervention 2: Control group:This group will receive only lidocaine hydrochloride 2% from Caspian Company in the amount of 2 ampoules of 5 mg in 100 cc without epinephrine and the amount of pain will be measured as the intervention group. Yes - There is a plan to make this available What will be shared: Information on the main consequences of the participants Published scientific study protocol on social networks such as researchgate A fully informed form of satisfaction When: 3 months after the publication of results To whom: Researchers working in academic and scientific institutions Conditions: In case of correspondence with the responsible author Where to obtain: Correspondence with the responsible author via email: azihsnkhani@zums.ac.ir How to obtain: Be a student or employee of government or university institutions Comments:
public Azadeh Hosseinkhani
N.1055 Ansarieh S. Valiasr S. Golestan 14.
Zanjan Iran (Islamic Republic of) 4513622411 +98 24 3336 2447 azihsnkhani@zums.ac.ir Zanjan University of Medical Sciences scientific Azadeh Hosseinkhani
N.1055 Golestan 14. Valiasr S. Ansarieh S.
Zanjan Iran (Islamic Republic of) 4513622411 +98 24 3336 2447 azihsnkhani@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Primigravida with Age 15 and Older Single Birth Cephalic Presentation The anterior position of the placenta Having Episiotomy Indications 15 years no limit Female Drug use History of Heart Disease Thyrotoxicosis Blood pressure above 130/90 Receiving Epidural or Spinal Anesthesia during Labor and before delivery Sensitivity History to Local Anesthetics Treatment - Drugs Treatment - Drugs Intervention group: injection of lidocaine hydrochloride 2% from Caspian company in the amount of 2 ampoules of 5 mg per 100 cc with epinephrine from 1: 200,000 and 10cc syringes will be used for all injections. Two minutes after the anesthetic injection, the patient's pain will be assessed by a visual analog scale, which, if the patient complains of pain, will be re-injected at half the previous dose. Control group:This group will receive only lidocaine hydrochloride 2% from Caspian Company in the amount of 2 ampoules of 5 mg in 100 cc without epinephrine and the amount of pain will be measured as the intervention group. The amount of pain during and after episiotomy. Timepoint: During episiotomy, after episiotomy, during episioraphy. Method of measurement: Visual analog scale (VAS). The amount of bleeding after episiotomy. Timepoint: During episiotomy, after episiotomy, during episioraphy. Method of measurement: Counting completely bloody Gauze. Tehran University of Medical Sciences Approved 2016-12-21 Ethics committee of Tehran University of Medical Sciences Ansarieh St., Valiasr St., Golestan 14, No. 1055, Unit 1 Zanjan Zanjan Iran (Islamic Republic of)