Is There a Relation Between Unilateral Epidural Block and Repeated Epidural Anesthesia?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- sensation
研究概览
简要总结
epidural block is today the most common method of pain relief during labor. With increased use of epidural analgesia, many women are found in the second or third pregnancy and require repeated epidural analgesia. But there was a higher incidence of unilateral blockade among women receiving their repeated epidural which causes patient unsatisfaction.
Objectives: Examination of the performance and outcome of women receiving their first versus repeated epidural block.
Patients and methods: The study included 140 American Society of Anesthesiologists (ASA) Physical Status II patients (age range 20 to 40 years) and scheduled for normal vaginal delivery. The patients were divided randomly into two equal groups. Group (A) in which 70 women primipara subjected to their first epidural block while group (B) in which 70 women multipara subjected to their repeated epidural block. For each patient, the following data were collected: demographic data, details of labor (gestation, cervical dilatation), visual analogue scale (VAS) before the epidural and 30 minutes after injection of local anesthetic and incidence of unilateral block.
详细描述
This study was performed after obtaining approval from the ethical committee of the Ain Shams University. Sample of 140 healthy ASA II female patients, 20-40 years of age, scheduled for normal vaginal delivery. Patients were randomly allocated by computer-generated random number list into two study groups of 70 patients each.
Group (A) in which 70 primipara women subjected to their first epidural block while group (B) in which 70 multipara women subjected to their repeated epidural block. The study was carried out between January 2018 and March 2018.
Patients were excluded for:
- Any physical reason for difficult epidural performance e.g.: morbid obesity, or scoliosis,
- Severe hypertension,
- Congestive heart failure,
- Coagulopathy,
- Significant hepatic or renal disease,
- Or withdrawal of consent. All patients in this study were subjected to a detailed pre-anesthetic evaluation. All basic investigations according to the hospital protocol (e.g. serum hemoglobin, platelet count, coagulation profile) were checked.
The patient's demographic data, details of labor (gestation, cervical dilatation), details of epidural insertion were recorded by the anesthetist performing the epidural.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy ASA II female patients,
- •20-40 years of age,
- •scheduled for normal vaginal delivery.
排除标准
- •- Any physical reason for difficult epidural performance e.g.: morbid obesity, or scoliosis,
- •Severe hypertension,
- •Congestive heart failure,
- •Coagulopathy,
- •Significant hepatic or renal disease,
- •Or withdrawal of consent.
研究组 & 干预措施
primipara
primipara subjected to their first epidural block
干预措施: marcaine (Drug)
multipara
multipara subjected to their repeated epidural block.
干预措施: marcaine (Drug)
结局指标
主要结局
sensation
时间窗: 30 minutes after injection of local anesthetic
by cold skin test
次要结局
未报告次要终点
研究者
RAMY AHMED
lecturer
Ain Shams University