Enhanced vs Conventional Recovery After Breast Surgery

Sponsor

Amal Gouda Elsayed Safan (Other)

Overall Status

Recruiting

CT.gov ID

NCT05931796

Collaborator

Mahmoud Saeed Ebaid (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Satisfaction	Other: NON-ERAS pathway Other: ERAS pathway	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 10, 2023

Anticipated Primary Completion Date :

Sep 10, 2023

Anticipated Study Completion Date :

Oct 10, 2023

Arms and Interventions

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 .

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 .

Outcome Measures

Primary Outcome Measures

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

Time of first ambulation [48 hours]
hours

Other Outcome Measures

Anesthesia recovery time [hour]
minutes
Time to regular diet. [24 hours]
hours
Postoperative opioid use. [48h]
mg

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Menoufia university	Cairo	Shibin Elkom	Egypt

Sponsors and Collaborators

Amal Gouda Elsayed Safan
Mahmoud Saeed Ebaid

Investigators

Principal Investigator: Mahmoud Saeed Ebaid, Menoufia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amal Gouda Elsayed Safan, lecturer of anaethesia, Menoufia University

ClinicalTrials.gov Identifier:

NCT05931796

Other Study ID Numbers:

3/2023ANET45

First Posted:

Jul 5, 2023

Last Update Posted:

Jul 5, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 5, 2023