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IRCT20220129053861N1 IRCT 2022-02-11 Qazvin University of Medical Sciences Comparison of Diclofenac suppository and Lidocaine ointment in controling episiotomy site pain Comparison of diclofenac suppository with topical lidocaine procaine ointment in controlling episiotomy site pain in primiparous women 2022-01-21 anticipated 120 Complete https://irct.ir/trial/61588 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using random allocation softeware software, 120 patients are divided into A and B by balanced block randomization method. The size of each block is 8 and the total number of blocks is 15. There are 60 patients in each group. Therefore, the balanced randomization method for participants is used to study a randomized clinical trial to evaluate the effect of diclofenac suppository and lidocaine-procaine ointment in controlling episiotomy pain. 3 Episiotomy pain control. Intervention 1: Intervention group: Immediately after episiotomy Diclofenac suppository 50mg (Aboreyhan company)is used, then it is repeated every eight hours according to the patient's need with a maximum dose of 150 mg. If the patient does not need it and there is no pain, she can not receive the next dose and if additional painkillers are needed before the specified time,she can use Acetaminophen 500mg(shefa company). Intervention 2: Intervention group: Intervention group: For group B, immediately after delivery, 2.5 ٪ 2.5% topical Lidocaine Procaine cream (Tehranchemie company)is used and then repeated every eight hours according to the patient's needs. The drug is given to the patient 8,16,24 hours later. If the patient does not need it and there is no pain, she can not receive the next dose of the drug. If she needs analgesia before the specified time, she can use acetaminophen 500 mg(shefa company). Yes - There is a plan to make this available What will be shared: . When: . To whom: . Conditions: . Where to obtain: . How to obtain: . Comments:
public Fatemeh Mirzapour
Floor 3,No 11,Fajr 4th alley,Bahar e sharghi street,Sar e Jangal blvd,Tehran
Tehran Iran (Islamic Republic of) 14 7695 3854 +98 21 4444 0496 Sadafmirzapourr@gmail.com Qazvin University of Medical Sciences scientific Masoumeh Dadashaliha
Taleghani street,Kowsar hospital
Qazvin Iran (Islamic Republic of) ۳۴۱۵۶-۱۳۱۷۶ +98 28 3323 6374 m.dadashaliha@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Primiparous women Age range 18-40 Spontaneous onset of labor Singleton pregnancy Cephalic presentation of fetus Mediolateral episiotomy in natural delivery 18 years 40 years Female Postpartum hemorrhage Use of forceps and vacuum for childbirth Manual removal of placenta (placenta corage) Contraindications to Nonsteroidal Anti-inflammatory drugs Multiple perineal rupture Treatment - Drugs Treatment - Drugs Intervention group: Immediately after episiotomy Diclofenac suppository 50mg (Aboreyhan company)is used, then it is repeated every eight hours according to the patient's need with a maximum dose of 150 mg. If the patient does not need it and there is no pain, she can not receive the next dose and if additional painkillers are needed before the specified time,she can use Acetaminophen 500mg(shefa company) Intervention group: Intervention group: For group B, immediately after delivery, 2.5 ٪ 2.5% topical Lidocaine Procaine cream (Tehranchemie company)is used and then repeated every eight hours according to the patient's needs. The drug is given to the patient 8,16,24 hours later. If the patient does not need it and there is no pain, she can not receive the next dose of the drug. If she needs analgesia before the specified time, she can use acetaminophen 500 mg(shefa company) Sevirity of Episiotomy site pain. Timepoint: 8,16,24 hour after episiotomy and then day 3 and 7 after episiotomy. Method of measurement: Visual analogue scale. Number of Diclofenac suppository use. Timepoint: 8,16,24 hour after episiotomy then day 3,7. Method of measurement: Record the frequency of use of medications received. Number of Lidocaine Procaine Ointments use. Timepoint: 8,16,24 hour after episiotomy then day 3,7. Method of measurement: Record the frequency of use of lidocaine procaine ointment. Frequency of use of additional analgesic. Timepoint: Before the specified time to receive the next dose of analgesia if patient needs. Method of measurement: Record frequency of additional analgesic use. Patient satisfaction. Timepoint: Day 3,7 after episiotomy. Method of measurement: Ask patient by phone. Qazvin University of Medical Sciences Approved 2021-09-19 Ethics committee of Qazvin University of Medical Science Medicine faculty,Qazvin University of Medical Science,Bahonar blvd,Qazvin Qazvin Qazvin Iran (Islamic Republic of)