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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Patient Satisfaction

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