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

Not Applicable

Not yet recruiting

• Conditions: ERAS
• Interventions: Other: Traditional postoperative care; Other: ERAS community recommendation

• Registration Number: NCT06225557
• Lead Sponsor: Minia University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-01-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-05
• Study Start: 2024-03-10
• Primary Completion: 2024-05-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional methods	Traditional postoperative care	Traditional methods in postoperative care for elective cesarean section will be followed.
ERAS society guidlines	ERAS community recommendation	The ERAS society guidelines for elective cesarean section will be followed.

Primary Outcome Measures

Name	Time	Method
Obstetric Quality of Recovery 11 score (ObsQoR-11)	before discharge or during 24 hour postoperatively	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