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NCT05931796 Clinical Trial

Enhanced vs Conventional Recovery After Breast Surgery

Patient Satisfaction Clinical Trial

Official title:
Enhanced Recovery vs Conventional Recovery After Anesthesia for Patients Undergoing Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05931796
Other study ID # 3/2023ANET45
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 10, 2023
Est. completion date January 25, 2024

Study information
Verified date January 2024
Source Menoufia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date January 25, 2024
Est. primary completion date September 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• NON-ERAS pathway
All patients received best of care practice, with standardization of preoperative and postoperative care
• ERAS pathway
ERAS pathway ERAS consist of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions .

Locations
Country Name City State
Egypt Menoufia university Cairo Shibin Elkom

Sponsors (2)
Lead Sponsor Collaborator
Amal Gouda Elsayed Safan Mahmoud Saeed Ebaid

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Other Anesthesia recovery time minutes hour
Other Time to regular diet. hours 24 hours
Other Postoperative opioid use. mg 48h
Primary 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 Time of first ambulation hours 48 hours
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