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

Cesarean Delivery Clinical Trial

Official title:

Implementation of ERAS Protocol for Cesarean Delivery in Clinical Center Vojvodina

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04058444
• Other study ID #: 0712960805046
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2019
• Est. completion date: June 2020

Study information

• Verified date: September 2019
• Source: University of Novi Sad
• Contact: Borislava Pujic, PhD
• Phone: +381641503577
• Email: borislava60[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Delivery

Intervention

Combination Product:
• ERAS protocol
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

Locations

Country	Name	City	State
Serbia	Obstetric and Gynecology Hospital	Novi Sad	Vojvodina

Sponsors (1)

Lead Sponsor	Collaborator
Pujic Borislava

Country where clinical trial is conducted

Serbia, 

References & Publications (3)

Gamez BH, Habib AS. Predicting Severity of Acute Pain After Cesarean Delivery: A Narrative Review. Anesth Analg. 2018 May;126(5):1606-1614. doi: 10.1213/ANE.0000000000002658. Review. — View Citation

Krohg A, Ullensvang K, Rosseland LA, Langesæter E, Sauter AR. The Analgesic Effect of Ultrasound-Guided Quadratus Lumborum Block After Cesarean Delivery: A Randomized Clinical Trial. Anesth Analg. 2018 Feb;126(2):559-565. doi: 10.1213/ANE.0000000000002648 — View Citation

Valentine AR, Carvalho B, Lazo TA, Riley ET. Scheduled acetaminophen with as-needed opioids compared to as-needed acetaminophen plus opioids for post-cesarean pain management. Int J Obstet Anesth. 2015 Aug;24(3):210-6. doi: 10.1016/j.ijoa.2015.03.006. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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