Enhanced vs Conventional Recovery After Breast Surgery
Enhanced Recovery vs Conventional Recovery After Anesthesia for Patients Undergoing Breast Surgery
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2023
CompletedFirst Submitted
Initial submission to the registry
June 2, 2023
CompletedFirst Posted
Study publicly available on registry
July 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2024
CompletedJanuary 26, 2024
January 1, 2024
6 months
June 2, 2023
January 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (1)
Time of first ambulation
48 hours
Other Outcomes (3)
Anesthesia recovery time
hour
Time to regular diet.
24 hours
Postoperative opioid use.
48h
Study Arms (2)
Group A
ACTIVE COMPARATORNON-ERAS pathway All patients received best of care practice, with standardization of preoperative and postoperative care
Group B
ACTIVE COMPARATORERAS pathway ERAS consist of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions .
Interventions
All patients received best of care practice, with standardization of preoperative and postoperative care
ERAS pathway ERAS consist of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions .
Eligibility Criteria
You may qualify if:
- Age: 20-60 years.
- Adequate cognitive state (able to understand and collaborate)
- American society of anesthesia (ASA) I, II
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amal Gouda Elsayed Safanlead
- Mahmoud Saeed Ebaidcollaborator
Study Sites (1)
Menoufia university
Cairo, Shibin Elkom, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmoud Saeed Ebaid
Menoufia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- lecturer of anaethesia
Study Record Dates
First Submitted
June 2, 2023
First Posted
July 5, 2023
Study Start
March 10, 2023
Primary Completion
September 10, 2023
Study Completion
January 25, 2024
Last Updated
January 26, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share