A Study on Short term and Long term Effects of Labour Epidural Analgesia in Parturients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Caeserean Section )
研究概览
简要总结
Abstract :
AIM :
This study is to assess the Short term and Long term effects of Labour Epidural Analgesia in
Parturients in comparison with parturients without labour epidural analgesia.
METHODOLOGY :
STUDY DESIGN : Observational study
After obtaining informed written consent, a structured proforma will be used to fill
the parturient’s - Name, Age, Hospital Number, Diagnosis, Co-morbidities, Gestational age,
Cervical dilatation, Phone number.
260 patients divided into two groups with 130 patients in each group.
A Questionairre will be filled by the primary observer after the first day of placement
of epidural catheter to observe the outcome and short term adverse effects of labour
epidural analgesia. Similarly the same questionairre will be filled by the primary investigator
for the control group. The control group will be chosen by the Obstetrician - parturients with
similar demographics of Epidural group.
Group A - Parturients with Labour Epidural Analgesia (130)
Group B - Parturients without labour epidural Analgesia (130)
PRIMARY OBJECTIVE : To study the outcome of labour in parturients with labour epidural
analgesia.
SECONDARY OBJECTIVE : To study the incidence of various other adverse effects of labour
epidural analgesia in parturients like :
Short Term
-
Motor Block
-
Hypotension
-
Headache
-
Nausea/Vomiting
-
Urinary Retention
-
Pruritis
-
Duration of 1st and 2nd stage of labour
Long Term
- Back Pain
Score/ Scale Used:
- Mode of Delivery - Normal Vaginal Delivery/Instrument assisted delivery/
Caeserean Section
-
Back pain - Numeric Pain Scale, Self report (Yes/No)
-
Motor Block - Bromage score
-
Adverse effects of epidural analgesia like hypotension, pruritis, nausea, urinary
retention, headache (Yes/No)
- Duration of second stage of labour ( Prolonged 2nd stage - >180 minutes)
The primary observer will follow up the patient through telephone after 3 months for both
the groups to note the long term adverse effects.
Long Term Effects :
- Back Pain - Numeric Pain Scale, Self report (Yes/No) If yes, impact of back pain on
daily activities and sleep(Yes/No)
With the above information we hope to find out the outcome of labour and adverse
effects in parturients with labour epidural analgesia in comparison with parturients without
labour epidural analgesia.
OUTCOME :
-
To find out the outcome of labour in parturients with labour epidural analgesia.
-
To find out short term and long term adverse effects -
a) Back pain
b) Motor Block
c) Hypotension, Pruritis, Nausea, Urinary retention, headache
d) Outcome of labour
e) Duration of second stage of labour
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Parturient requesting for labour epidural analgesia
- •Parturient with singleton pregnancy
- •Cephalic presentation with no CPD.
排除标准
- •Women suffering from back pain before pregnancy due to the diagnosed spinal pathology or past history of back injuries.
- •Epidural contraindications.
- •Coagulopathy, Local site infection, septicemia, Raised ICP
- •Anatomical deformity of Spine
- •Allergy to local anaesthetics
- •Elective C.
结局指标
主要结局
Caeserean Section )
时间窗: 24 hours
To find out the outcome of labour in parturients with labour epidural analgesia. (Normal Vaginal Delivery/Instrument assisted delivery/
时间窗: 24 hours
次要结局
- Motor Block(24 hours)
- Hypotension(24 hours)
- Headache(24 hours)
- Nausea/Vomiting
- Urinary Retention(24 hours)
- Pruritis(24 hours)
- Duration of 1st and 2nd stage of labour(24 hours)
- Back pain(3 months)
研究者
L R P PRASHIN
Christian Medical College