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

NCT06225557 | Not Yet Recruiting

• 1 other identifier: 383/08/2022
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ERAS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ERAS society guidlines

EXPERIMENTAL

The ERAS society guidelines for elective cesarean section will be followed.

Other: ERAS community recommendation

Traditional methods

EXPERIMENTAL

Traditional methods in postoperative care for elective cesarean section will be followed.

Other: Traditional postoperative care

Interventions

ERAS community recommendation OTHER

Enhanced recovery techniques including opioid sparing anesthesia in elective cesarean section

ERAS society guidlines

Traditional postoperative care OTHER

Usual anesthesia and analgesia in elective cesarean section.

Traditional methods

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Officials

• Ahmad EZ Mahran, professor

  Faculty of Medicine, Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa AA Mohamed, AS Lecturer

CONTACT

00201005431155; marwaelhelaly@hotmail.com

Haidy SM Mansour, AS professor

CONTACT

00201221802324; haydi.mansour@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: follow ERAS society guidelines recommendations in elective CESAREAN SECTION

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 26, 2024
• Study Start: March 10, 2024
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03