The First ERAS Protocol for Cesarean Delivery in Serbia at the University Hospital

Study Overview
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Brief Summary
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This study is designed to help us with ERAS (Enhanced Recovery After Surgery) Protocol for Cesarean Delivery implementation with goal to improve patient satisfaction and decrease length of stay at hospital. This will improve patient treatment and decrease total hospital costs.

Detailed Description
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ERAS assumes cooperation between obstetricians, anesthesiologists and parturient. This is the new concept because patient have an active role in the whole process. Pregnant patient receives the first information about ERAS from obstetrician and anesthesiologist before the scheduled cesarean delivery. Patient condition optimization is necessary. Antibiotic prophylaxis, no bowel preparation and arriving to the hospital on the day of surgery are basic principles. All patients are done under spinal anesthesia. DVT (Deep Venous Thrombosis) prophylaxis starts postoperatively. Early mobilization, early oral intake and urinary catheter removal on the day of surgery with multimodal analgesia is mandatory.

Official Title
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Implementation of ERAS Protocol for Cesarean Delivery in Clinical Center Vojvodina

Conditions
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Cesarean Delivery

Intervention / Treatment
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* Combination Product: ERAS protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All healthy patients from 18-45 years for scheduled Cesarean Delivery Exclusion Criteria: Age younger then 18 years old and older then 45 years Urgent and emergent Cesarean Delivery Preeclampsia Contraindications for spinal anesthesia Abnormal placentation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS Group<br>Perioperative management follows the ERAS (Enhanced Recovery After Surgery) protocol | Combination Product: ERAS protocol<br>* No routine bowel preparation Antibiotics prophylaxis PONV (Postoperative Nausea and Vomiting) prophylaxis Spinal anesthesia Post- Cesarean analgesia (Acetaminophen 1g IV q6h, Tramadol 50mg IV q6h, Quadratus lumborum Block Oral pain relief medication Pain scores every day (VAS) Hospital length of stay Patient satisfaction<br>|
| Experimental: Control Group<br>Perioperative management follows the conventional program | Combination Product: ERAS protocol<br>* No routine bowel preparation Antibiotics prophylaxis PONV (Postoperative Nausea and Vomiting) prophylaxis Spinal anesthesia Post- Cesarean analgesia (Acetaminophen 1g IV q6h, Tramadol 50mg IV q6h, Quadratus lumborum Block Oral pain relief medication Pain scores every day (VAS) Hospital length of stay Patient satisfaction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Cesarean pain scoring | Visual Analog Scale (VAS) for pain assessment (scale from 0-10). Score 0 to 5 is satisfactory pain control. Score 6 to 10 is not a good pain control and is necessary to add medication. | Measured from postoperative day (PO) Day 0 to PO day 3 (72 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Length of stay might influence on cost savings. Investigator expects discharge hospital will be on the PO day 3. | PO Day 0 until time of discharge PO Day 3-4 (72-96 hours) | 
| Post-partal depression development | Inadequate postoperative treatment could cause chronic pain which could be the reason for post- partal depression development. Six weeks after delivery investigator will call mothers for interview and fill the Edinburgh Postnatal Depression Scale. Score 10 and more is suspect for depression risk. | Measured from the Cesarean Delivery to 6 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean delivery, ERAS protocol