Episiotomy Wound Clinical Trial
Official title:
Comparison Between the Effects of Lidocaine Prilocaine Cream and Lidocaine Injection on Reduction of Perineal Pain During Episiotomy and Perineum Repair in Vaginal Delivery: Randomized Control Trial
The present study aims to compare the effects of lidocaine-prilocaine cream and lidocaine injection on the reduction of pain while doing and repairing episiotomy, controlling the pain in the post-partum period, and reduction the risk of infection and dyspareunia in 6 weeks post-partum.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Pregnant women candidate for VD ( ASA ? ) 2. Primigravida 3. Pregnant more than 37 weeks (Term pregnancy). 4. Singleton fetus. 5. Cephalic presentation. 6. In first stage of labor. Exclusion Criteria: 1. More than or equal 1 previous CS and VBAC. 2. Multiparous women. 3. Pregnant less than 37 weeks 4. Twin pregnancy. 5. Not in active labor 6. allergy to lignocaine 7. altered mental status 8. request for epidural analgesia 9. Hepatic impairment. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cairo University |
Dahlen HG, Homer CS, Cooke M, Upton AM, Nunn RA, Brodrick BS. 'Soothing the ring of fire': Australian women's and midwives' experiences of using perineal warm packs in the second stage of labour. Midwifery. 2009 Apr;25(2):e39-48. doi: 10.1016/j.midw.2007.08.002. Epub 2007 Nov 26. — View Citation
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Kargar R, Aghazadeh-Nainie A, Khoddami-Vishteh HR. Comparison of the Effects of Lidocaine Prilocaine Cream (EMLA) and Lidocaine Injection on Reduction of Perineal Pain During Perineum Repair in Normal Vaginal Delivery. J Family Reprod Health. 2016 Mar;10(1):21-6. — View Citation
Lullmann B, Leonhardt J, Metzelder M, Hoy L, Gerr H, Linderkamp C, Klein C, Grigull L. Pain reduction in children during port-a-cath catheter puncture using local anaesthesia with EMLA. Eur J Pediatr. 2010 Dec;169(12):1465-9. doi: 10.1007/s00431-010-1244-1. Epub 2010 Jul 10. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of the Intervention on pain score during the repair of episiotomy | Efficacy of lidocaine-pridocaine cream in pain control for episiotomy incision and repair assessed by Visual Analogue Score VAS during episiotomy incision and repair where the minimum value is equal to zero which means no pain at all and the maximum value is equal to 10 and this means the worst pain ever. | 1 year | |
Secondary | Effect of the Intervention on pain score and dyspareunia during 6 weeks postpartum | Pain score and dyspareunia in the first week post-partum and 6 weeks post-partum will be assessed by Customer Satisfaction Score or CSAT score, where the minimum value is very unsatisfied and associated with the highest degree of pain and the maximum value is very satisfied and this associated with the lowest degree of pain in the period of 1 week and 6 weeks. | 1 year | |
Secondary | Effect of the Intervention on perineal infection during 6 weeks postpartum | Detection of the infection rates 6 weeks post-partum as this is the period of perpurium when puerperal sepsis may develops. | 1 year |
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