Clinical trial NCT04058444: The First ERAS Protocol for Cesarean Delivery in Serbia at the University Hospital
Official title: Implementation of ERAS Protocol for Cesarean Delivery in Clinical Center Vojvodina
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Delivery
Keywords: cesarean delivery
ERAS protocol
Lead sponsor: University of Novi Sad
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-Cesarean pain scoring
timeFrame: Measured from postoperative day (PO) Day 0 to PO day 3 (72 hours)
Secondary outcomes:
measure: Hospital length of stay
timeFrame: PO Day 0 until time of discharge PO Day 3-4 (72-96 hours)
measure: Post-partal depression development
timeFrame: Measured from the Cesarean Delivery to 6 weeks postoperatively
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Obstetric and Gynecology Hospital
state: Vojvodina
Study officials:
affiliation: Obstetric and Gynecology Hospital, Novi Sad, Serbia
name: Borislava Pujic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. Epub 2015 Mar 23.
citation: Krohg A, Ullensvang K, Rosseland LA, Langesaeter 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.