Efficacy and feasibility of Enhanced Recovery After Surgery (ERAS) protocol on functional recovery in women undergoing elective caesarean delivery: A randomized clinical trial

Thisprospective randomized clinical trial is being planned to compare efficacy and feasibility of Enhanced Recovery after Surgery (ERAS) protocol implementation vs. routine perioperative care in women undergoing elective cesarean delivery. The primary objective is to compare pain control in terms of Numerical rating scale (NRS). As secondary outcome; postoperative recovery, need for rescue analgesics, adherenceto ERAS protocols and factors leading to non-adherence, patient’s readiness for dischargefrom maternity unitwith ERAS protocolvs. routine perioperative care, patient satisfaction on Likert scale; will also be noted. Postoperative recovery will be noted in terms of time taken by patients to achieve postoperative milestones such as tolerance to diet, resumption of bowel function, ambulation and postoperative complications if any.

The purpose of the present study is to evaluate the efficacy and feasibility of ERAS implementation in achieving functional recovery in women undergoing elective cesarean section in Indian scenario.

Study has been approved by the Institute Ethics committee. Antenatal women booked in the Department of Obstetrics and Gynaecology at All India Institute of Medical Sciences, New Delhi and planned for elective caesarean delivery will be recruited according to the inclusion and exclusion criteria. After explaining the detailed plan and purpose study in their own language and giving a copy of Patient Information Sheet, informed written consent will be taken on a preformed consent form. Enrolled women will be randomized into two groups (70 patients in each group) according to computer generated randomization table. Patients in group 1 will be managed with ERAS protocol and patients in group 2 will be the control group managed with traditional protocol.
Patients will be operated by different surgeons, but all patients will be cared for in the same ward.

ERAS protocol will involve three components:

Preoperative preparationwithEducation/Counseling, Preoperative oral intake, Prophylactic antibiotics, Aspiration prophylaxis.

Intraoperative Optimizationwith Standard anesthetic protocol, Skin cleansing, preventing hypothermia, Skin to skin care and delayed cord clamping, Intra-operative oxytocin, Prophylaxis for postoperative nausea and vomiting, Perioperative fluid and blood pressure management.

Postoperative optimizationwith adequate pain management, postoperative chewing gum, encouraging early oral intake, mobilization, breastfeeding and catheter removal.