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OpenTrials
Completed

NCT Number: NCT05931796

Enhanced vs Conventional Recovery After 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.

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Key information

Conditions

Patient Satisfaction Behavior Health Behavior Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia university

Cairo, Shibin Elkom, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NON-ERAS pathway

Other

All patients received best of care practice, with standardization of preoperative and postoperative care

ERAS pathway

Other

ERAS pathway ERAS consist of approximately 15 elements (or components) that include preoperative, intraoperative, and postoperative interventions .

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.

    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.

Secondary outcomes

  1. Time of first ambulation

    Time frame: 48 hours

    hours

Other outcomes

  1. Anesthesia recovery time

    Time frame: hour

    minutes

  2. Time to regular diet.

    Time frame: 24 hours

    hours

  3. Postoperative opioid use.

    Time frame: 48h

    mg

Sponsors and collaborators

Lead sponsor

Amal Gouda Elsayed Safan

Other

Collaborators

  • Mahmoud Saeed Ebaid

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 5, 2023
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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