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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of the Intervention on pain score during the repair of episiotomy
研究概览
简要总结
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 in 6 weeks post partum and dyspareunia after 6 weeks post-partum.
详细描述
Population of study & disease condition:
The study will be conducted on 60 patients that will be admitted to the labor ward in the Department of Obstetrics & Gynecology of a tertiary care center of Cairo University from Jan/2023 to Jan/2024 on. Primigravida women with singleton live pregnancy with cephalic presentation in the first stage of labor will be included in the study after approval by the Institutional Ethical Committee and obtaining an informed consent. Those with known allergy to lignocaine, altered mental status, request for epidural analgesia and hepatic disorders will be excluded from the study. The enrolled women will be divided into two groups by simple randomization with a 1:1 allocation ratio.
The following will be done to all participants:
- Informed written consent: after discussing the nature of the study as well as the expected value, outcome, and possible adverse effects.
- Full medical history: including full obstetric history and current pregnancy history (entailing the 1st day of LMP).
- Thorough Clinical Examination: general (vital signs) and full obstetric examination.
- Obstetric ultrasonography: to confirm gestational age and the eligibility of the current pregnancy to participate in the study.
This will be a randomized controlled trial, randomization will be achieved by the following: the allocation treatment will be written on cards that will be sealed in sequentially numbered envelopes. The envelopes will be opened at the time of allocation after the enrolled participants will complete all baseline assessments. Group I comprised 30 women who will receive 10 ml of lidocaine 2% for perineal infiltration at the time of crowning while 30 women of Group II will have lidocaine prilocaine cream 15gm application on the perineum at 8 cm of cervical dilatation and then additional dose every 1 hour until delivery is achieved, then another dose of the cream will be applied before repairing the episiotomy and finally daily 3 doses every 8 hours at the site of episiotomy for the first week post-partum. Lidocaine prilocaine cream, an eutectic mixture, is composed of Lidocaine-25 mg, Prilocaine-25 mg, Arlactone 289 -19 mg, Carbopol-10 mg, Sodium hydroxide to make a pH of 9.6 mg and purified water to produce l gram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This will be a randomized controlled trial, randomization will be achieved by the following: the allocation treatment will be written on cards that will be sealed in sequentially numbered envelopes. The envelopes will be opened at the time of allocation after the enrolled participants will complete all baseline assessments. Group I comprised 30 women who will receive 10 ml of lidocaine 2% for perineal infiltration at the time of crowning while 30 women of Group II will have lidocaine prilocaine cream 15gm application on the perineum at 8 cm of cervical dilatation and then an additional dose every 1 hour until delivery is achieved, then another dose of the cream will be applied before repairing the episiotomy and finally daily 3 doses every 8 hours at the site of episiotomy for the first week post-partum.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women candidate for VD ( ASA Ⅱ )
- •Primigravida
- •Pregnant more than 37 weeks (Term pregnancy).
- •Singleton fetus.
- •Cephalic presentation.
- •In first stage of labor.
排除标准
- •More than or equal 1 previous CS and VBAC.
- •Multiparous women.
- •Pregnant less than 37 weeks
- •Twin pregnancy.
- •Not in active labor
- •allergy to lignocaine
- •altered mental status
- •request for epidural analgesia
- •Hepatic impairment.
研究组 & 干预措施
Group I comprised 30 women who will receive 10 ml of lidocaine 2%
10 ml of lidocaine 2% for perineal infiltration at the time of crowning
干预措施: 10 ml of lidocaine 2% (Drug)
Group II will have lidocaine prilocaine cream 15gm application on the perineum
lidocaine-prilocaine cream 15gm application on the perineum at 8 cm of cervical dilatation and then an additional dose every 1 hour until delivery is achieved, then another dose of the cream will be applied before repairing the episiotomy and finally daily 3 doses every 8 hours at the site of episiotomy for the first week post-partum
干预措施: lidocaine prilocaine cream 15gm (Drug)
结局指标
主要结局
Effect of the Intervention on pain score during the repair of episiotomy
时间窗: 1 year
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.
次要结局
- Effect of the Intervention on pain score during 6 weeks postpartum and dyspareunia after 6 weeks post partum(1 year)
- Effect of the Intervention on perineal infection during 6 weeks postpartum(1 year)