Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration for First Trimester Incomplete Miscarriage in Abakaliki: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Mean pain score using the Visual analogue scale
研究概览
简要总结
Miscarriage is one of the major causes of early pregnancy losses. Incomplete miscarriage is a major cause of maternal morbidity and mortality. Analgesia from both conscious sedation and paracervical could be utilized during manual vacuum aspiration of first trimester incomplete miscarriage. The objectives of this study are to review the existing studies and to compare analgesia from conscious sedation with that of paracervical block among women selected for manual vacuum aspiration following first trimester incomplete miscarriages in Alex Ekwueme Federal University Teaching Hospital, Abakaliki [AEFUTHA].
详细描述
SUMMARY
Background:
First trimester pregnancy losses are estimated to occur in 14-19% of all clinically confirmed pregnancies and account for about 80% of all the pregnancy losses. Miscarriage is one of the major causes of early pregnancy losses. Incomplete miscarriage is a major cause of maternal morbidity and mortality.
Analgesia from both conscious sedation and paracervical could be utilized during manual vacuum aspiration of first trimester incomplete miscarriage. In my center, conscious sedation is mostly used but because of the pronounced systemic side effect of drowsiness, weakness etc, there is a shift to paracervical block hence this study.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •- Between the ages of 18- 45 years.
- •Spontaneous incomplete miscarriage at less than 13 weeks.
- •Not allergic to drugs for the study
- •Patients that give consent
排除标准
- •- Patients who do not consent to MVA [ Manual vacuum aspiration].
- •Those with known allergy history to the drug agents.
- •Those with septic incomplete miscarriage.
- •Patients with infection at the cervical blocking sites.
- •Those with active pelvic inflammatory disease.
- •Patients with neurological or psychiatric disease.
- •Incomplete miscarriage at greater than 13 weeks.
研究组 & 干预措施
GROUP A (Conscious Sedation)
30mg of pentazocine was given intravenously, over one minute and a latency period of about 2 minutes was allowed before starting the procedure for analgesic function to take effect.
干预措施: Lidocaine (Drug)
GROUP B (The Paracervical Block)
Received 10 ml of 1% lidocaine, for the blocks with 4ml at 4 O' clock and 8 O'clock positions and 2 ml at the anterior cervical lip.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Mean pain score using the Visual analogue scale
时间窗: Pain and side effects experienced following the use of the analgesic agents at about 10 minutes, 2 hours, 6 hours, 12 hours and 24 hours following the procedure was noted. Higher score showed more pain and lower score showed lower pain
The primary outcome measure is the mean pain score of the participants in the study groups.
次要结局
未报告次要终点
研究者
Darlington-Peter Chibuzor Ugoji
Principal Investigator
Alex Ekwueme Federal University Teaching Hospital