Comparison of Outcome Between (ERACS) Versus Traditional Methods in Elective CS

ERAS Clinical Trial

— ERACS  

Official title:

Comparison of Outcome Between the Implementation of Enhanced Recovery After Elective Cesarean Section Protocol (ERACS) Versus Traditional Methods

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06225557
• Other study ID #: 383/08/2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 10, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Minia University
• Contact: Marwa AA Mohamed, AS Lecturer
• Phone: 00201005431155
• Email: marwaelhelaly[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to evaluate the effect of implementing enhanced recovery after surgery (ERAS) protocol during elective cesarean section on patient's outcome measures.

Description:

The study is designed to evaluate the effect of implementing enhanced recovery after surgery (ERAS) protocol during elective cesarean section on patient outcome measures. The primary outcome is the evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery 11 score (ObsQoR-11) at the time of discharge.

Secondary outcomes are the evaluation of peak numeric postoperative pain rating score within the postoperative hospital stay, total amount of postoperative opioid consumption, postoperative nausea, and vomiting impact score after 6 hours postoperatively and at time of discharge, patient satisfaction using Leiden perioperative care patient satisfaction questionnaire (LPPSq) at time of discharge, presence of post-cesarean ileus and Hospital length to achieve criteria for discharge.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Pregnant women ASA I to ASA II aged from 18 up to 40 years. With non-complicated pregnancy undergoing elective CS.

Exclusion Criteria:

• -Age less than 18 years

• Complications (wound infection, re-exploration, caesarean hysterectomies)

• Recent documented use of opioids Allergy to any drug used during the study.-

• Patients with severe heart diseases, cardiac arrhythmia and myocardial injury.

• uncontrolled diabetic patient

• Severe liver and kidney diseases

• Coagulation defect

Related Conditions & MeSH terms

• ERAS

Intervention

Other:
• ERAS community recommendation
Enhanced recovery techniques including opioid sparing anesthesia in elective cesarean section
• Traditional postoperative care
Usual anesthesia and analgesia in elective cesarean section.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obstetric Quality of Recovery 11 score (ObsQoR-11)	it is consisted of 11 questions covers four domains of recovery outcomes: physical comfort, emotional state, physical independence and care of the neonate, and pain ,each question taking score from 0 to 10 with 0 is the minimum score and 10 is the highest score and the maximum total score is 110 and the minimum total is 0 which is the worest quality of recovery	before discharge or during 24 hour postoperatively