Enhanced vs Conventional Recovery After Breast Surgery

Not Applicable

Completed

• Conditions: Patient Satisfaction
• Interventions: Other: NON-ERAS pathway; Other: ERAS pathway

• Registration Number: NCT05931796
• Lead Sponsor: Amal Gouda Elsayed Safan

Brief Summary

the investigators hypothesize that with the use of enhanced recovery of surgery (ERAS), the postoperative hospital stay after breast surgeries is reduced and also postoperative complications are decreased.

Detailed Description

Group A NON-ERAS pathway All patients received best of care practice, with standardization of preoperative and postoperative care. Group B ERAS pathway

Study Timeline

• Study Start: 2023-03-10
• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-05
• Primary Completion: 2023-09-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Study Completion: 2024-01-25
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• • Age: 20-60 years.

  • Adequate cognitive state (able to understand and collaborate)
  • American society of anesthesia (ASA) I, II

Exclusion Criteria

• Patients who are:

  • Uncooperative.
  • Having allergy to any of the study drugs.
  • Known abuse of alcohol or medication.
  • Having Local infection at the site of injection or systemic infection.
  • Pregnancy.
  • With coagulation disorders.
  • Any complicated patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	NON-ERAS pathway	NON-ERAS pathway All patients received best of care practice, with standardization of preoperative and postoperative care
Group B	ERAS pathway	ERAS pathway ERAS consist of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions .

Primary Outcome Measures

Name	Time	Method
This study aims to explore the effectiveness and safety of the enhanced recovery after surgery (ERAS) protocol vs. traditional perioperative care programs for modified radical mastectomy.	48 hours	visual analogue scale VAS Score (a scale from 0 to 10 where 0 is interpreted as no pain, 1- 4 mild pain, 5-6 moderate pain, 7-10 severe pain) will be recorded 15 min after extubation (as soon as the patient will be alert enough to report pain)' every 1hour for the first 8hours' then every 3hours for the remaining 24 hours.

Secondary Outcome Measures

Name	Time	Method
Time of first ambulation	48 hours	hours

Trial Locations

Locations (1)

Menoufia university; 🇪🇬 Cairo, Shibin Elkom, Egypt