The Effect of Lidocaine - Prilocaine Cream (EMLA) Versus Mepivacaine Infiltration on Pain Relief During And After Mediolateral Episiotomies: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- pain
研究概览
简要总结
Included women were divided randomly into two groups:
Group A: (n=100): women were subjected to application of EMLA® cream "Lidocaine-prilocaine cream (EMLAcream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and 2.5% prilocaine)"for pain relief during episiotomy repair.
Group B: (n=100): women were subjected to application of local injection of 10 ml of 1% mepivacaine for pain relief during episiotomy repair.
详细描述
During the second stage of labor, women were placed in the lithotomy position. 10- Patients who were enrolled in the study were guaranteed to obtain additional anesthesia during episiotomy repair whenever pain exceeded the tolerability threshold.
11- Volunteers were assigned randomly to have either local injection of 10 ml of 1% mepivacaine or application of 5gm-dose® EMLA cream"Lidocaine- prilocaine cream(EMLA cream; Astra Zeneca, Basiglio, Italy is an entectic mixture of 2.5% lidocaine and 2.5% prilocaine)" for pain relief during episiotomy repair.
- Group A: "EMLA group"
- Women who were assigned randomly to receive EMLA cream had a 5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate pemetration thrug stratum corneum
- EMLA cream was applied, 1 hour before the expected time of birth.
- With the assistance at birth, the residue of cream was removed to prevent contact with the fetus, because sodium hydroxide, which is a component of the cream, can cause fetal eye irritation.
- No additional anesthetic was applied if episiotomy was necessary.
- Before commancement of perineal repair any residual cream was wiped off.
- Group B: "mepivacaine infiltration group".
- In the mepivacaine group, 10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.
- In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.
- The suture procedure was delayed 10 minutes after the injection of the aneathetic
- All episiotomies were performed at the top of contraction as mediolateral episiotomies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age 37 weeks or more
- •Singleton gestation.
- •Uncomplicated pregnancy.
- •Vertex presentation.
排除标准
- •Epidural analgesia request.
- •Operative delivery.
- •No other methods are used for pain control 2hours befor episiotomy
- •Previous adverse reaction to local anesthetic.
研究组 & 干预措施
Lidocaine-prilocaine cream
Women who were assigned randomly to receive EMLA cream had a 5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate pemetration thrug stratum corneum
- EMLA cream was applied, 1 hour before the expected time of birth.
- With the assistance at birth, the residue of cream was removed to prevent contact with the fetus, because sodium hydroxide, which is a component of the cream, can cause fetal eye irritation.
- No additional anesthetic was applied if episiotomy was necessary.
- Before commancement of perineal repair any residual cream was wiped off.
干预措施: Lidocaine-prilocaine cream (Drug)
Lidocaine-prilocaine cream
Women who were assigned randomly to receive EMLA cream had a 5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate pemetration thrug stratum corneum
- EMLA cream was applied, 1 hour before the expected time of birth.
- With the assistance at birth, the residue of cream was removed to prevent contact with the fetus, because sodium hydroxide, which is a component of the cream, can cause fetal eye irritation.
- No additional anesthetic was applied if episiotomy was necessary.
- Before commancement of perineal repair any residual cream was wiped off.
干预措施: mediolateral episiotomy (Procedure)
mepivacaine infiltration group
- In the mepivacaine group, 10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.
- In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.
- The suture procedure was delayed 10 minutes after the injection of the aneathetic
干预措施: mepivacaine infiltration group (Drug)
mepivacaine infiltration group
- In the mepivacaine group, 10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.
- In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.
- The suture procedure was delayed 10 minutes after the injection of the aneathetic
干预措施: mediolateral episiotomy (Procedure)
结局指标
主要结局
pain
时间窗: 24 hours after delivery
The patient was asked to mark the point that best indicated the perception of her pain on the visual analog scale
次要结局
未报告次要终点