To assess the association of Spinal Anaesthesia with Chronic Low Back Pain Following Childbirth: A Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 528
- 试验地点
- 1
- 主要终点
- To compare the incidence of chronic low back pain following childbirth in patients receiving spinal anaesthesia for Caesarean delivery versus in patients undergoing vaginal delivery without any anaesthesia technique
研究概览
简要总结
This is an observational, prospective study to assess the association of spinal anaesthesia with chronic low back pain following childbirth
The objectives of this study are -
1.To compare the incidence of chronic low back pain following childbirth in patients receiving spinal anaesthesia for caesarean delivery versus in patients undergoing vaginal delivery without any anaesthesia technique
2.To compare the severity of chronic low back pain following childbirth in the two study groups
3.To determine the incidence of chronic low back pain following childbirth in the cohort of patients presenting in our hospital
4.To study the association of physical factor during pregnancy and childbirth, with chronic low back pain following childbirth
The trial will be conducted in the department of anaesthesiology and department of obstetrics and gynaecology of Hamdard Institute of Medical Sciences and Research
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.All women who deliver at HAHC Hospital either vaginally without anaesthesia, or cesarean delivery under spinal anaesthesia 2.The patient must be registered in Ante Natal Clinic at HAHC Hospital.
排除标准
- •1.Patients with preexisting low back pain before pregnancy, diagnosed lumbar spinal pathologies and diagnosed psychiatric disorders including depression and anxiety 2.Refusal to participate in study 3.Patients developing any complication after childbirth, requiring wound resuturing or have a complication for which they have to undergo any surgery within 3 months.
结局指标
主要结局
To compare the incidence of chronic low back pain following childbirth in patients receiving spinal anaesthesia for Caesarean delivery versus in patients undergoing vaginal delivery without any anaesthesia technique
时间窗: D0 - day of delivery | D1 - 1st follow up in person | D7 - 2nd follow up telephonically | D90 - 3rd follow up telephonically
次要结局
- 1.To compare the severity of chronic low back pain following childbirth in the two study groups(2.To determine the incidence of chronic low back pain following childbirth in the cohort oof patients presenting in our hospital)
研究者
Runjhun Aggarwal
Hamdard Institute of Medical Sciences and Research, New Delhi