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Clinical Trials/NCT06225557
NCT06225557
Not yet recruiting
Not Applicable

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

Minia University0 sites106 target enrollmentMarch 10, 2024
ConditionsERAS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ERAS
Sponsor
Minia University
Enrollment
106
Primary Endpoint
Obstetric Quality of Recovery 11 score (ObsQoR-11)
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 10, 2024
End Date
June 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Minia University
Responsible Party
Principal Investigator
Principal Investigator

Marwa Abdelrehim Attia Mohamed

Assistant lecturer

Minia University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Obstetric Quality of Recovery 11 score (ObsQoR-11)

Time Frame: 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

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