Enhanced vs Conventional Recovery After Breast Surgery

January 24, 2024 updated by: Amal Gouda Elsayed Safan

Enhanced Recovery vs Conventional Recovery After Anesthesia for Patients Undergoing Breast Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Shibin Elkom
      • Cairo, Shibin Elkom, Egypt
        • Menoufia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
NON-ERAS pathway All patients received best of care practice, with standardization of preoperative and postoperative care
Other: NON-ERAS pathway
All patients received best of care practice, with standardization of preoperative and postoperative care
Active Comparator: Group B
ERAS pathway ERAS consist of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions .
Other: ERAS pathway
ERAS pathway ERAS consist of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of first ambulation
Time Frame: 48 hours
hours
48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthesia recovery time
Time Frame: hour
minutes
hour
Time to regular diet.
Time Frame: 24 hours
hours
24 hours
Postoperative opioid use.
Time Frame: 48h
mg
48h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amal Gouda Elsayed Safan

Collaborators

Mahmoud Saeed Ebaid

Investigators

  • Principal Investigator: Mahmoud Saeed Ebaid, Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2023

Primary Completion (Actual)

September 10, 2023

Study Completion (Actual)

January 25, 2024

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 3/2023ANET45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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