A quality improvement initiative to enhance fast recovery after scheduled cesarean section in a referral hospital

Completed

• Conditions: Obstetrics,

• Registration Number: CTRI/2022/05/042844
• Lead Sponsor: JIPMER

Brief Summary

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|**Procedures**  (please provide details, including data collection procedures, their timing, and frequency, standardization of relevant techniques, etc.)

The quality improvement project will be undertaken after the approval from JIPMER scientific and ethics committee and it will implemented as mentioned below

**Project Implementation Plan:**

The project team would follow the PDSA (Plan – Do – Study – Act) quality initiative model to implement ERAS protocols in caesarean section. Broadly, quality improvement would be implemented in three phases**.**

**Phase I (Baseline period): 3 months:**In this phase, we shall make no new changes to the system. We shall measure the baseline rates of various outcomes – D2 discharge rate, overall hospital stay, readmission rate within four weeks, composite adverse maternal outcome (SSI, UTI, nausea/vomiting, and paralytic ileus), usage of opioid-sparing analgesia for women undergoing elective caesarean deliveries. We shall form a QI team consisting of a team leader, coordinators from obstetrics, anaesthesiology and neonatology, a senior resident from obstetrics and anaesthesiology, nursing college and a member from JQC.  We shall try to understand the possible barriers for initiation and implementation of ERAS protocol for elective caesarean sections in our setting through flow mapping and fishbone analysis.

 **Phase II (Implementation period): 6 months:**

The ERAS – 10 protocol will be implemented in this phase over a period of 6 months. At the end of every month, the team wouldconduct a series of plan-do- study-act (PDSA) cycles to identify the barriers and would generate possible solutions/ideas to overcome it. This would be done on monthly basis and   the effect of new solutions/ ideas identified will be assessed by the proportion of women discharged on D2 following elective caesarean deliveries in the subsequent month. We shall track the outcome using run charts and present them in monthly department audit meetings.

**ERAS- 10: periopeartive care pathways for implementation (Annexure II)**

Our ERAS protocol is divided into ten components for easy remembrance, adherence, and for assessment of compliance

1.     **Pre-op education and pre-anaesthetic assessment**: Education/information about caesarean section and breastfeeding using pamphlets/educational videos (in Tamil- prepared after multidisciplinary inputs from faculty /residents/nursing staff of OG, anaesthesia and neonataology) will be given to women after 36 weeks in the antenatal period by nursing students under supervision and pre-anaesthetic assessment on or before the day of surgery. All patients scheduled will be assessed by PAC team members for fitness and risk assessment before surgery.

2.     **Pre-op admission and fasting strategy**: Hospital admission will be made one day before the scheduled surgery if possible. Light meal will be allowed six hours before surgery. A clear carbohydrate drink[[AK1]](applewebdata://89D8086E-AEE9-4A34-8724-A32EBA201AAB#_msocom_1) will be allowed two hours before surgery. No bowel preparation is done.

3.     **Aspiration prophylaxis**: Oral famotidine 20 mg in the night and in the morning. Oral metoclopramide 10 mg in the morning 2 hours before surgery.

4.     **Sterility strategy**: Intravenous prophylactic antibiotics[[AK2]](applewebdata://89D8086E-AEE9-4A34-8724-A32EBA201AAB#_msocom_2)  1 hour before surgery, Sterile on table urinary catheterization before spinal anaesthesia. Chlorhexidine-alcohol preparation of the abdomen, povidone-iodine solution for vaginal preparation, and povidone-iodine solution for RA preparation.

5.     **Anaesthesia strategies**: Single-shot spinal anaesthesia with intra-thecal bupivacaine and fentanyl, co-loading of warm ringer lactate 5 to 8 ml/kg ( maximum 500 ml) over 15 to 20 minutes and maintainence rate of 2 to 3 ml/kg/hr, active management of hypotension with vasopressors like phenylepherine 25 to 50 ug,  optimal administration of oxytocin ( 10 U of oxytocin diluted in 100 ml NS fluid over 1 hour). If uterine tone is atonic, additional 5 to 10 U will be added to infusion. Intra-myometrial carboprost 0.25 mg and rectal misoprostol 1mg will be administered for further uterine atony. Prophylactic anti-emetic administration for post-operative nausea and vomiting ( ondansetron 4 mg) will form the anaesthetic strategies.

6.     **Surgical strategies**: Use of minimally invasive techniques for opening the abdomen, blunt expansion of uterine incision, double layer in-situ uterine closure, a minimal effective dose of oxytocin, non-closure of the parietal peritoneum, approximation of subcutaneous fat if the thickness is >2cm, and subcuticular closure for the skin.

7.     **Hypothermia prevention**: Administration of warm intraoperative and postoperative fluids, warm blankets, and active use of warming devices to prevent hypothermia.

8.     **Post-op analgesia and mobilization:** At the end of surgery all patients will receive 0.25% bupivacaine 15 to 20 ml of subcutaneous infiltration. All patients will receive both NSAID and paracetamol alternatively in the postoperative period; Moderate pain (VAS 3-6) will be treated with IV tramadol. Severe pain (VAS > 7) will be treated with intravenous fentanyl bolus doses (0.25 to 0.5 ug/kg) and number of bolus doses within 48 hours will be noted. Use of IM/IV morphine will be avoided. Urinary catheter will be removed 6 hours after surgery followed by active mobilization.

9.     **Initiation of orals**: Sham feeding with chewing gum within half an hour of surgery. To allow clear oral fluids  2 hours after surgery and soft diet 6 hours after surgery

10.  **Neonatal care**: Delayed cord clamping (after 30-60 seconds), skin-to-skin contact, and early breastfeeding.

**Phase III (Sustenance period): 3 months:**During this period, we shall evaluate the continued implementation of ERAS-10 and its impact on D2 discharge, overall stay in the hospital, 30-day readmission rate, composite adverse maternal outcome, usage of opioid-sparing analgesia and adherence to 10 point ERAS protocol (complete or partial)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-06
• Last Update Posted: 2024-09-25

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

Pregnant women aged between 18-45 years with a singleton pregnancy at term and scheduled for elective caesarean section under regional analgesia at JIPMER.

Exclusion Criteria

1.Pregestational / gestational diabetes on insulin 2.Pre-eclampsia with severe features 3.Suspected sepsis in the antepartum period 4.Maternal heart disease which comes under modified WHO class III/IV 5.Major degree placenta praevia/placenta accreta spectrum.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To implement ten key components of ERAS among pregnant women undergoing elective caesarean section at term and to target achieving 80% Day 2 (D2) discharge from the hospital, compared to the baseline rate of 10% over a period of one year.	48 hours

Secondary Outcome Measures

Name	Time	Method
To study the impact of the implementation of ERAS among pregnant women undergoing elective caesarean section at term in JIPMER on the following outcomes before and after implementation of ERAS:	1.Initiation of early breastfeeding

Trial Locations

Locations (1)

JIPMER; 🇮🇳 Pondicherry, PONDICHERRY, India

JIPMER

🇮🇳Pondicherry, PONDICHERRY, India

Dr Aswini Kuberan

Principal investigator

9914017949

ashdoctor.kuberan@gmail.com