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临床试验/CTRI/2024/04/065365
CTRI/2024/04/065365尚未招募2/3 期

Comparing the enhanced recovery after caesarean delivery with conventional care in maternal outcome: A randomised controlled study.

S Nijalingappa medical college1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年4月17日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
Decreased length of stay and early discharge.

研究概览

简要总结

Enhanced recovery after caesarean delivery (ERAC) is a comprehensive multidisciplinary protocol based with well-defined perioperative interventions with inclusion of anesthesiologists, obstetricians, pediatricians, nurses, patients, and hospital administration. The activity of ERAC begins from the time of preoperative assessment and extends into the postoperative period with the threefold aim of providing best quality of care, cutting down cost and improving patient satisfaction level.

The aim of this study is to implement predefined ERAC protocol for the better management of elective caesarean section patients and its comparison with existing traditional protocol to evaluate the barriers in its implementation, to provide better quality of care and reduce financial burden.

PRE-OPERATIVE PERIOD

In conventional care, pre-operatively the pregnant women is counselled about the procedure and explained about the nil per oral of 8hrs for both solid and liquid. Antibiotics may not be strictly given and intravenous fluids maybe started prior to surgery.

In ERAC pre-operatively the pregnant women will be counselled about the procedure and explained about the nil per oral of 8 hours for solids and 2 hours prior to surgery, clear liquids of around 600ml will be given to the pregnant women. [clear liquids-pulp free juice, coconut water , electrolyte solution, tea/coffee without milk] Saline lock  i.e no intravenous fluids are given to the pregnant women preoperatively.[7] Intravenous antibiotic Inj Ceftriaxone 1g will be given 60 minutes prior to the surgery.

INTRA-OPERATIVE PERIOD

In conventional care, during intraoperative period the room temp is not controlled. The pregnant woman is shifted to operation theatre with secured and patent 18G IV cannula, all ASA standard monitors are attached and baseline haemodynamic parameters [HR, NIBP, SpO2] are recorded. Povidine iodine solution is used for skin preparation. Spinal anaesthesia is given with Inj Bupivacaine heavy 2.2ml. Intravenous fluids are given liberally. No prophylactic vasopressors are used to prevent hypotension [Maternal Hypotension is defined as 1) a decrease in systolic blood pressure of more than 20% from baseline measurements or (2) a systolic blood pressure lower than 100 mm Hg.] Inj Mephentermine 6mg is given intravenously if there is hypotension. Breast feeding is usually initiated after shifting to Post-operative room which varies from immediate to few hours after shifting.

In ERAC, the room temperature will be set to 23 degree Celsius, pregnant women  is shifted to operation theatre with secured and patent 18G IV cannula, all standard monitors are attached and baseline haemodynamic parameters [HR, NIBP, SpO2] are recorded. Spinal anaesthesia will be given with Inj Bupivacaine heavy 2.2ml + Inj Fentanyl 20 mcg.  Skin preparation will be done using Chlorhexidine solution. Controlled intravenous fluid management is done. Prophylactically vasopressors – Inj Phenylephrine infusion will be given at the rate of 25-50 mcg/min to prevent hypotension. Immediately after delivery of the baby , skin to skin contact of the baby with mother and immediate breast feeding is initiated.

POST-OPERATIVE PERIOD

In conventional care anti-emetic Inj.Ondansetron 4mg is given SOS. Post-operative pain is managed by Inj Diclofenac BD IM and Inj Paracetamol 8th hourly. Foleys catheter removal after 24 hours. Mother will be discharged on the 5th day.

In ERAC post-operatively anti-emetic Inj Ondansetron 4mg BD 12th hourly for 24 hrs is continued. The pain score of the mother will be assessed using VAS score [0-No pain 10-Worst pain] and multimodal analgesia will be given with Inj Paracetamol 1g 100ml 8th hourly and Inj Ketorolac 30mg stat intravenously and followed by 15mg IV every 6th hour for the duration of 24 hours , as and when the mother complains of pain ,considering maximum dose of 120mg/day. For any break  through pain(VAS>4) Inj Tramadol 100mg intravenous infusion will be given. Early oral intake has been preferred within 12 hours of the surgery. Foleys  catheter will be removed within 12 hours of the surgery. Early ambulation will be done within 6 hours of the surgery. Mother will be discharged on the 3rd  day.

Implementation of ERAC probably decreases the length of stay and able to discharge early , better maternal satisfaction and maternal bonding with the baby. It also helps in decreasing the burden on maternal socio-economic status and health care system.

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
21.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1] Age group :21-45 years women having gestational age more than 37 weeks 2] Elective caesarean deliveries done under Spinal Anaesthesia 3] ASA (American Society Of Anaesthesiologists) physical status II.

排除标准

  • 1] Refusal to Enroll for the study 2] Any contraindications for spinal anaesthesia 3] Multiple gestation 4] Hypertensive disorders of pregnancy 5] Uncontrolled diabetes mellitus 6] Obesity BMI more than 40kg/m2 7] Other obstetric complications during surgery like post-partum hemorrhage, bladder injury, bowel injury [will be excluded from the study] 8] Any other medical illness like anemia, cardiac diseases, renal diseases.

结局指标

主要结局

Decreased length of stay and early discharge.

时间窗: 72 hours

次要结局

  • Better maternal satisfaction and maternal bonding with the baby. It also helps in decreasing the burden on maternal socioeconomic status and health care system.(72 hours)

研究者

发起方
S Nijalingappa medical college
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Ramesh Koppal

S NIjalingappa Medical college

研究点 (1)

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