跳至主要内容
临床试验/CTRI/2024/02/063200
CTRI/2024/02/063200招募中不适用

A two arm, single centre, prospective, randomized, interventional study to evaluate the effect of ERAS pathway Vs traditional methods in patients undergoing Lower Segment Cesarian Section (LSCS).

Bhaktivedanta Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年3月18日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
94
试验地点
1
主要终点
1. To check the efficacy of predefined ERAS protocol for better management of elective cesarean section patients.

研究概览

简要总结

1. Current guidelines of Enhanced Recovery After Surgery (ERAS) recommend food and liquid intake perioperatively  6 hours and 2 hours respectively, for caesarean section to prevent complications.  ERAS accelerates patient recovery by standardizing perioperative care, including preoperative counselling and early mobilization. A study in India found that ERAS improved breastfeeding initiation, with 50.5% starting within the first hour and 34.7% within 2 to 4 hours postoperatively, compared to traditional care. ERAS also led to earlier ambulation, catheter removal, and reduced analgesic requirement, resulting in higher Quality of Recovery (QoR) scores at 24 hours postoperative. Despite the significant body of evidence indicating that ERAS protocols lead to improved outcomes, they challenge traditional surgical doctrine, and as a result their implementation has been slow. Therefore this study is being conducted with an objective to implement predefined ERAS protocol for better management of elective cesarean section patients, to compare quality of recovery based on obstetric-specific QoR 11 questionnaire. between patients undergoing ERAS and traditional protocol for elective LSCS, To compare the intensity of pain using Visual Analog Scale (VAS) score, Comparison of total duration of hospitalization between ERAS and traditional protocols, To evaluate the requirement of analgesics within 24 hours between both groups, To evaluate the duration in which the mobilization was initiated post operatively between both group.

  1. All pregnant patients with gestational age ≥ 34 weeks, Patients under ASA grade I-II, Patients scheduled for elective cesarean section surgery will be included in the study. However, the patients with preexisting cardiac disease, extreme preterm labor < 34 weeks, diabetes, autoimmune disorder, severe and uncontrolled hypertension. , severe uncontrolled hypo/hyperthyroidism. patients with antepartum hemorrhage i.e., abruption placenta and placenta previa will be excluded from the study

  2. This study is two arm in which the patients will be randomized based on computer based randomization technique

  3. The patients who are randomized in Arm 1 (Control group) will follow the traditional method i.e.  “fasting from midnight” which includes no food before 12 hours and no liquid intake before 6 hours perioperatively.

  4. The patients who are randomized in Arm 2 (Interventional group) will follow ERAS pathway procedure which includes the following

A. Preoperative procedures a day before the surgery.

a.     Education:

§  Dedicated preoperative counselling.

§  Counselling for enhanced protocol which will include details of ERAS program: its goals and benefits, spinal anaesthesia, benefits of early skin to skin contact and breast feeding.

B. On the day of surgery:

§  Fasting for solid 6 h prior to surgery

§  Clear liquid will be allowed till 2 h before surgery.

§  25 g of glucose dissolved in 200 ml of water 2 h before surgery

C. Post surgery:

A.    Resumption of oral intake

§  Chewing gum/Lozenges and sips of water at 2h.

§  Clear fluid/juices at 4 h. Semisolid at 8 h after surgery.

B.    Mobilization

§  Early mobilization within 6 h of surgery.

The patients enrolled in both the groups will be assessed based on following questionnaire:

A.    The recovery will be assessed by using the recovery based on obstetric-specific QoR 11 questionnaire in the timepoint of 12 hours ,24 hours postoperatively and at the timepoint of discharge.

B.    The pain will be evaluated by using Visual Analog Scale (VAS Scale) on the day of surgery, 12 hours and 24 hours postoperatively and at the timepoint of discharge.

C.    At the timepoint of discharge (Day n): The patient feeding, mobilization patterns and QOL will be captured by using “Patient Questionnaire” which is validated and approved by EC

The data parameters includes the above mentioned questionnaires as well as , total hours within which attempt for mobilization was performed, total hours within which breast feeding was initiated,requirement of analgesics within 24 hours, total hours within which the catheter was removed post operatively, number of days of hospitalization, duration in which the bowel movement is back to normal, need for readmission of the patient (Yes/No) will be recorded

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
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • All pregnant patients with gestational age ≥ 34 weeks
  • Patients under ASA grade I-II
  • Patients scheduled for elective cesarean section surgery.

排除标准

  • 未提供

结局指标

主要结局

1. To check the efficacy of predefined ERAS protocol for better management of elective cesarean section patients.

时间窗: At the timepoint of surgery, 24 hours post surgery, discharge

次要结局

  • To compare the changes in the OBS QOL score in both the group , to compare the changes in VAS score in both the groups(24 hours post surgery, discharge)

研究者

发起方
Bhaktivedanta Hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Kamalapriya Thiyagarajan

Bhaktivedanta Hospital and Research Institute

研究点 (1)

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