Opioid-Free Anesthesia in Modified Radical Mastectomy

January 11, 2023 updated by: Etienne El Helou

Efficacy of Opioid-Free Anesthesia in Modified Radical Mastectomy

The aim of this study is to evaluate the efficacy of opioid-free general anesthesia for breast surgeries in female patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Lebanese Hospital Geitaoui-University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Between January 2018 and September 2020, data from admitted patients for modified radical mastectomy under general anesthesia were enrolled.

Description

Inclusion Criteria:

  • Patients underwenting modified radical mastectomy
  • Undergoing general anesthesia

Exclusion Criteria:

  • Patients were excluded if they had Alzheimer's Disease, mental retardation, failure of locoregional anesthesia, contraindication for locoregional anesthesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 consisting of treated patients using OFA
Group 1 consisted of 56 (Mean age was 54±14 years)
Group 2 consisting of treated patients using NOFA
Group 2 consisted of 60 patients (Mean age was 51±12 years)
Procedure: opioid anesthesia
opioid-free general anesthesia vs non opioid-free general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative Morphone use
Time Frame: up to 24 hours
Patients who received Morphine at different time points in function of the two study groups
up to 24 hours
Time To Extubation (TTE)
Time Frame: Directly intraOp
Time to Extubation in function of the two study groups
Directly intraOp

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Nausea and Vomiting (PONV)
Time Frame: Up to 24hours
Patients who had PONV at different times in function of the two study groups
Up to 24hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Etienne El Helou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

December 16, 2022

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HelouAssaf

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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