A Randomized Controlled Trial of Bupivacaine With Epinephrine for Local Pain Control Following Perineal Laceration Repair in Patients With Pre-existing Epidural Analgesia: The PAIN Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Time to first analgesic
研究概览
简要总结
Postpartum pain can interfere with patient's ability to care for themselves, and their newborn, and untreated pain is associated with risk of greater opioid use, postpartum depression, and development of persistent pain. The research hypothesis of this study is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain and improve women's overall well-being and satisfaction.
The objective of this study is to determine if prolonged analgesia and higher rate of maternal satisfaction are found when bupivacaine with epinephrine infiltration is used for perineal repair as compared to sham injection in patients with pre-existing effective epidural analgesia at time of perineal laceration repair.
详细描述
Perineal lacerations, the disruption of the skin, mucosa and sometimes muscles that happen commonly during vaginal birth secondary to stretching of the introitus; are present in more than 75% of all vaginal deliveries. These lacerations can be classified based on the location and depth (layers injured). However, the classification of these lacerations does not correlate necessarily with postpartum pain. Severe lacerations, as those compromising the external or internal anal sphincter are less common and associated with more postpartum pain.
It is common practice that only those lacerations causing bleeding, or distortion of normal pelvic anatomy are repaired. The repair of such lacerations at Montefiore Einstein is usually done using lidocaine for non-epiduralized patients; however, for patients with a functional epidural, no anesthetic agents are given locally to aid on long term pain control.
The prevalence of perineal lacerations is more than 75% of all vaginal deliveries. The repair of such lacerations in the institution is usually done using lidocaine for non-epiduralized patients versus no local injection in patients with a pre-existing epidural analgesia. The prevalence of epidural analgesia use among women who underwent vaginal delivery in cross-sectional study of over 2 million deliveries in the United States was 71.1%. Once the analgesic effect of the epidural analgesia fades, the laceration may cause uncontrolled postpartum pain which can affect both the physical and mental recovery period, extend hospital stays, and increase the potential for serious adverse reactions with pain medications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be blinded to the patient, the nurse carrying for the patient and providing the randomized, unlabeled syringe, the provider performing the perineal repair, the research team asking the maternal satisfaction questions, and the researcher analyzing the data. To assure blinding, the selection of the medication given, and the preparation of such medication will be performed by the labor and delivery anesthesia team. No one involved directly in the perineal laceration repair, or obtaining research information, nor the patient, will know what was injected. Subject treatment assignments will remain blinded until the final subject has completed follow up and all data has been recorded and validated. Urgent, immediate unblinding due to medical emergency may be authorized by the Investigator. When possible, the treatment assignment will be provided to the treating physician to maintain the blind for the Investigator and study staff.
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
- •Healthy with a singleton pregnancy
- •English or Spanish speaking
- •Ongoing functioning epidural throughout the laceration repair
- •Multiparous or nulliparous
- •Ability to consent for themselves
排除标准
- •Underwent an operative vaginal delivery and whose vaginal delivery was complicated by a postpartum hemorrhage
- •Have multiple gestations
- •Complaints of non-functioning epidural
- •Allergic to bupivacaine and/or epinephrine
- •Received an epidural top-off (bolus of local anesthetic injected into the epidural catheter) < 3 hours from the perineal repair
- •Experienced extreme pain at time of study consent (pain scale score > 3 on 0-10 scale)
研究组 & 干预措施
Normal saline sham arm
干预措施: Sham normal saline arm (Other)
Local Anesthesia arm
Bupivicaine and Epinephrine
干预措施: Epinephrine (Drug)
Local Anesthesia arm
Bupivicaine and Epinephrine
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Time to first analgesic
时间窗: Up to 24 hours after perineal laceration
Average time to first analgesic (TFA) will be evaluated per patient as the duration interval following injection to administration of the first analgesic, as applicable.
Pain score after injection at perineal laceration
时间窗: Immediately and 24 hours after perineal laceration
Participants will self-report measures of symptoms using the Visual Analog Scale (VAS) to determine acute and chronic pain. Participants record a single handwritten mark at one point along the length of a 10-cm line that represents a continuum between the two ends of a scale where "no pain" is on the left end (0 cm) of the scale and the "worst pain" is on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as the intensity of pain. The values will be used to track pain progression for a patient and to compare pain between patients with similar conditions
Maternal Satisfaction
时间窗: 7 days after perineal laceration
Maternal satisfaction will be assessed by participants' rating their ability to carry out their daily living activities at 24hrs using a 4-point scale (very poor; poor; good; or very good)
次要结局
未报告次要终点