Clinical post operative outcomes in patients undergoing Elective LSCS:Comparing ERAS and Tradition Management – A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Primary outcome: Quality of recovery assessed by QoR-11 score within 24 hours postoperatively.
研究概览
简要总结
To compare clinical outcomes in patients undergoing LSCS based on ERAS and traditional postoperative care protocols.
Primary objective
To assess clinical outcomes in patients undergoing LSCS through ERAS versus traditional pathways.
Secondary objectives
To compare maternal satisfaction, readmission rates within 30 days, incidence of thromboembolic events, hospital cost per patient, and the need for additional post-discharge medical consultations.
To compare patient’s satisfaction and post operative complications between ERAS and traditional care protocols.
Study participants : All pregnant females scheduled for elective LSCS at term gestation who give written informed conset(can be taken by post graduate students or interns) at AIIMS Guwahati.
Inclusion criteria:
• Pregnant women at term with ASA physical status I or II.
Exclusion criteria:
• Patients with cardiac disease, uncontrolled hypertension or diabetes, autoimmune disorders, thyroid dysfunction, placental abnormalities, severe hepatic or renal dysfunction, neurological or psychiatric illness, or contraindications for spinal anaesthesia such as coagulopathy.
Study design : Prospective, single-center, randomized controlled trial.
Study setting and period : Department of Obstetrics and Gynaecology, AIIMS Guwahati over an 18-month period.
Intervention
Participants randomized into two groups:
ERAS group: received care as per evidence-based ERAS protocol including early oral intake, early ambulation, multimodal analgesia, and early catheter removal.
Traditional group: received standard institutional care involving delayed oral intake, routine opioid use, delayed ambulation and catheter removal.
Eligible patients will be identified during preoperative evaluation and approached by a research team member to explain the study purpose, methodology, and benefits. Written informed consent will be obtained, and baseline demographic and clinical information collected. Participants will then be randomized into either the ERAS protocol group or traditional care group using a sealed envelope method.Study Instruments and Tools
-
QoR-11 questionnaire (Quality of Recovery-11)
-
Visual analog scale (VAS) for pain
-
Well’s score for deep vein thrombosis (DVT) risk
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women at term with ASA physical status I or II.
排除标准
- •Patients with cardiac disease, uncontrolled hypertension or diabetes, autoimmune disorders, thyroid dysfunction, placental abnormalities, severe hepatic or renal dysfunction, neurological or psychiatric illness, or contraindications for spinal anaesthesia such as coagulopathy.
结局指标
主要结局
Primary outcome: Quality of recovery assessed by QoR-11 score within 24 hours postoperatively.
时间窗: Within 24 hours of LSCS, post-operative day 10 and day 42
Secondary outcomes: Length of hospital stay, Well’s score, maternal satisfaction, pain scores, early breastfeeding initiation, ambulation, catheter removal timing, readmission rates.
时间窗: Within 24 hours of LSCS, post-operative day 10 and day 42
次要结局
- Secondary outcomes: Length of hospital stay, Well’s score, maternal satisfaction, pain scores, early breastfeeding initiation, ambulation, catheter removal timing, readmission rates.
研究者
Taskeen Rehman
AIIMS Guwahati