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临床试验/CTRI/2025/07/090373
CTRI/2025/07/090373尚未招募不适用

Comparison of Enhanced Recovery After Cesarean protocol versus Traditional approach in elective lower segment cesarean section under spinal anaesthesia : A Prospective Observational Study.

Mahatma Gandhi Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2025年7月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
172
试验地点
1
主要终点
Comparison of total duration of stay (readiness to discharge) in the hospital between Enhanced Recovery After Caesarean Protocol and Traditional Approach

研究概览

简要总结

It is a hospital based prospective randomised observational study to be conducted by the Department Of Anaesthesiology, Mahatma Gandhi Medical College & Hospital.

The initiation of this study is contingent upon obtaining ethical clearance from the Institutional Ethics Committee (IEC). Comprehensive written and informed consent will be diligently obtained from all participating patients.

The sample size was estimated by using the formula for comparison of two independent mean. Anticipating a medium effect size of 0.5 in the day of readiness for discharge between the two groups, the minimum sample size required is 172 i.e., 86 in each group at 5 % level of significance and 90% power.

A multi disciplinary team comprising anaesthesiologists, obstetricians, neonatologists, and nursing professional, will gather to discuss the change in peri partum management of patient undergoing elective cesarean section. After going through various guidelines proposed by Society of Obstetric Anaesthesia and Perinatology, American College of Obstetrics and Gynaecology, and ERAC society and extensive discussion, strategies for standardization of care was decided. Broadly major components, which will be key to improved outcome according to previous research and found feasible to implement in our hospital will be included in the revised ERAC protocol.

Parturients undergoing traditional protocol will continue the routine practice of admission a day prior to surgery, with scheduled preoperative counselling, overnight fasting, and liberal fluid administration along with use of povidone iodine as a standard antiseptic for all aseptic procedures. Standard practice of day 2 mobilization and delayed catheter removal will be continued for them. In the ERAC protocol, parturients will be counselled in detail on antenatal visit about risks and complications associated with the procedure and will  also be sensitized about the ERAC program and its benefits. After thorough understanding of the ERAC components and approval, parturients will be asked to get admitted a day prior to surgery or on the day of surgery with advice to be followed at home for prior day. Alcohol based chlorhexidine solution will be used for asepsis except for vaginal toileting.

Pre-operative fasting will be reduced to 2 hrs for clear liquids and carbohydrate rich drinks will be given a night before and on the day of surgery to avoid hypoglycaemia. Neuraxial anaesthesia  (Sub-arachnoid Block; SAB) will be administered in both the protocols. In ERAC Protocol, USG guided Transversus Abdominis Plane block will be given for post-operative pain relief. In ERAC protocol, patients will receive fluid administration @15–20 ml/hr  and early feeding (within 2 hrs sips of water) early mobilization and de-catheterization within 6–10 hrs with multimodal analgesia to cover postoperative pain.

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

  • Patients scheduled for elective caesarean sections.
  • Age between 18 to 45 years.
  • American Society of Anaesthesiology grade I.

排除标准

  • Psychiatric/neurological illness, or coagulopathy.
  • Patients with Rh negative pregnancy, presence of any medical disorders during pregnancy and abnormal placentation.
  • Known allergy.
  • Individuals who underwent failed spinal anaesthesia and required conversion to general anaesthesia.

结局指标

主要结局

Comparison of total duration of stay (readiness to discharge) in the hospital between Enhanced Recovery After Caesarean Protocol and Traditional Approach

时间窗: 1. Pre-operative Examination. | 2. Intra-operative Examination. | 3. Post-operative variables.

次要结局

  • Comparison of VAS Scores and requirement of Analgesics in 24 hours.(0 hours, 2nd hour, 4th hour, 8th hour, 12th hour, 16th hour, 24th hour.)
  • Assessment of urinary retention and need of re-catheterisation.(Post-operatively.)
  • Assessment of adverse events like nausea, vomiting, shivering and respiratory depression.(Intra-operatively and Post-operatively.)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Arushi Johri

Mahatma Gandhi Medical College and Hospital

研究点 (1)

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