Early recovery after planned caesarean delivery

Not yet recruiting

Conditions: Pregnancy, childbirth and the puerperium,

Registration Number: CTRI/2020/10/028652

Lead Sponsor: All India Institute of Medical Sciences New Delhi

Brief Summary: 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, patientâ€™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.â€¨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 preparation**withEducation/Counseling, Preoperative oral intake, Prophylactic antibiotics, Aspiration prophylaxis.

**Intraoperative Optimization**with 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 optimization**with adequate pain management, postoperative chewing gum, encouraging early oral intake, mobilization, breastfeeding and catheter removal.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 140

Inclusion Criteria

Women planned for elective caesarean delivery with no significant obstetric and medical complication.

Exclusion Criteria

Patients with significant obstetric and medical complications.
Previous 2 or more LSCS or other abdominal surgeries or known case abdominal Kochâ€™s.
Contraindications for neuraxial anesthesia.
Not willing to participate in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numerical rating scale(NRS)	At 6 hours, 12 hours, 24 hours, 26 hours and 48 hours after caesarean

Secondary Outcome Measures

Name	Time	Method
-Need for rescue analgesics	-Postoperative recovery

Trial Locations

Locations (1): AIIMS, New Delhi
🇮🇳
Delhi, DELHI, India
AIIMS, New Delhi
🇮🇳Delhi, DELHI, India
Dr Vidushi Kulshrestha
Principal investigator
9891910880
drvidushi.kul@gmail.com