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IRCT20231025059855N1 IRCT 2023-12-23 Tehran University of Medical Sciences Topical lidocaine and pain reduction in natural childbirth Efficacy and safety of lidocaine-prilocaine topical cream (XYLA-P) in reducing the intensity of episiotomy pain in normal vaginal delivery 2023-12-16 anticipated 54 Complete https://irct.ir/trial/73355 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple, individual randomization. In this study, patients are placed in one of the study groups, including the intervention group and the control group, using the limited randomization method in the form of double-blind random allocation. Random allocation is done by cards numbered 1 and 2, Blinding description: Participants, as well as clinical caregivers and outcome evaluators in this study, were blinded to study group assignment. Participants in the intervention group receive medication and in the control group receive a placebo and do not know which group they are in. Midwives also don't know if they are using medicine or placebo. Also, the outcome evaluators who fill the questionnaire form after the procedure do not know which group the patient was in. 2-3 Natural Vaginal Delivery. Intervention 1: Intervention group: Before episiotomy and during episiotomy repair, according to the standard protocol, the intervention group receives 2% injectable lidocaine in the form of 5 cc injections and together with local injectable lidocaine, they receive 5 grams of lidocaine-prilocaine cream as a thick layer on the skin. This cream is used 30 minutes before the procedure at the episiotomy incision site. Intervention 2: Control group: The control group received injectable lidocaine and 5 grams of placebo (lubricant gel) as a thick layer on the skin. Yes - There is a plan to make this available What will be shared: The data about the participants such as demographic information and medical history, etc is shared without mentioning their names and main characteristics. Also, the results of the study, including the main results, will be provided. When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: If the individuals are approved, they can access the data and perform analysis on them by mentioning the source. Of course, they should not tamper with the data. Where to obtain: Clinical Research Development Unit, Baharloo Hospital, Behdari St, Rah Ahan Sq 00982155658500-11 internal no. 578 How to obtain: Submit your request through the announced communication portals. After conducting the necessary checks within one month's working time, the documents will be sent to your address. Comments:
public Bita Shahrami
Dr. Shariati Research and Treatment Center, Jalal Al Ahmad St, North Kargar St
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 bshahrami@sina.tums.ac.ir Tehran University of Medical Sciences scientific Bita Shahrami
Dr. Shariati Research and Treatment Center, Jalal Al Ahmad St, North Kargar St
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 bshahrami@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Healthy pregnant women with first natural delivery Gestational age between 37 and 41 weeks Episiotomy incision below 5 cm Patient satisfaction 20 years 35 years Female Heavy bleeding during childbirth The need to use a vacuum during delivery Grade 3 and 4 perineal lacerations History of previous allergy to lidocaine or prilocaine 080 Single spontaneous delivery Treatment - Drugs Treatment - Drugs Intervention group: Before episiotomy and during episiotomy repair, according to the standard protocol, the intervention group receives 2% injectable lidocaine in the form of 5 cc injections and together with local injectable lidocaine, they receive 5 grams of lidocaine-prilocaine cream as a thick layer on the skin. This cream is used 30 minutes before the procedure at the episiotomy incision site. Control group: The control group received injectable lidocaine and 5 grams of placebo (lubricant gel) as a thick layer on the skin. Intensity of pain. Timepoint: After the episiotomy and 1, 2, 4 and 24 hours after the episiotomy. Method of measurement: Visual Analogue Scale. Patient satisfaction rate. Timepoint: After the episiotomy and 1, 2, 4 and 24 hours after the episiotomy. Method of measurement: Oral questionnaire. Tehran University of Medical Sciences Approved 2023-10-17 Ethics committee of Tehran University of Medical Sciences Baharloo Hospital , Behdari St , Rah Ahan Sq Tehran Tehran Iran (Islamic Republic of)