Analgesic Benefit of Locally Injected Bupivacaine on Perineal Pain Among Women With Epidural Anesthesia After a Vaginal Delivery: a Randomized, Single-masked, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Proportion of women who have a Numeric Rating Scale (NRS) score≤4 at 6-hours (±30 minutes) after last epidural bolus (comparison between bupivacaine arm and the no analgesic arm)
研究概览
简要总结
The prevalence of birth canal lacerations is more than 70% of all deliveries in Canada. The repair of such lacerations is usually done using a pre-existing epidural analgesia. Once the analgesic effect of the epidural analgesia fades, the laceration may cause intolerable pain, and result in emotional stress, difficulties in ambulation and breastfeeding, and more.
The research team hypothesis is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain, prevent such difficulties, and improve women's overall well-being and satisfaction.
The proposed trial is a two-arm, single-masked, randomized trial. Women with a working epidural analgesia, and a laceration will be invited to participate. Women in the local anesthesia (LA) arm will get a LA injected to the laceration and women in the sham arm will get no injection. The differences in perineal pain between the groups will be evaluated at 6 hours after last epidural dose.
详细描述
- The Need for the Trial
1.1. Background
Perineal trauma during delivery may be iatrogenic (episiotomy) or spontaneous (perineal tear). First-degree injury involves the perineal skin only, while a 2nd-degree perineal tear (2PT) involves perineal muscles as well1,2. A 3rd-degree tear involves the anal sphincter, and a 4th-degree tear involves the entire anal sphincter complex (external and internal anal sphincters) and the anal epithelium1,2. An episiotomy (Epi) is usually performed in a mediolateral or lateral manner, and is considered a 2nd degree laceration by definition. The morbidity associated with obstetrical anal sphincter injury (3rd or 4th degree perineal tear) is considerably higher than in 1st or 2nd degree tear1,2.
The repair of a perineal tear may be done using the epidural anesthesia that was used during delivery, with no additional analgesia. If the patient is delivered without an epidural anesthesia, a short-acting local anesthetic agent, such as lidocaine, may be infiltrated to the edges of the wound prior to suturing.
Scope of the problem The annual number of deliveries in Canada approaches 390,000, of which more than 145,000 are anticipated to take place in Ontario3. It has been reported that approximately 70% of deliveries in Ontario are vaginal deliveries4. Episiotomies occur in approximately 20% of vaginal deliveries, with 50% a 1st or 2nd degree perineal tear occur, and 3.2% of vaginal deliveries are complicated by a 3rd or 4th degree perineal tear4,5.
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
- Double (Participant, Outcomes Assessor)
盲法说明
a randomized, single-masked, controlled trial
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Maternal age > 18 years of age
- •Gestational age≥34 weeks of gestation
- •Vaginal delivery
- •Perineal laceration (2PT/Epi)
- •Effective epidural anesthesia
- •No known hypersensitivity to bupivacaine or amino-amide anesthetics
排除标准
- •Medical history of a chronic pain syndrome
- •Intrapartum morphine use
研究组 & 干预措施
Bupivacaine arm
The edges of the 2PT/Epi will be infiltrated with 10ml of Bupivacaine 0.5%+Epinephrine 50mcg prior to suture placement.
干预措施: Bupivacaine 0.5%+Epinephrine 50mc (Drug)
Control arm
Sham injection will be done using a syringe filled with 10ml of NaCl 0.9%, but the fluid will not be injected to the edges of the laceration but discarded. The sham injection will last no less than 10 seconds.
干预措施: Sham injection (Other)
结局指标
主要结局
Proportion of women who have a Numeric Rating Scale (NRS) score≤4 at 6-hours (±30 minutes) after last epidural bolus (comparison between bupivacaine arm and the no analgesic arm)
时间窗: 6-hours (±30 minutes) after last epidural bolus.
Comparison between the bupivacaine arm and the no analgesic arm in terms of pain score at 6-hours.
次要结局
未报告次要终点