NCT05693402

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

2.7 years

First QC Date

December 16, 2022

Last Update Submit

January 11, 2023

Conditions

SurgeryAnesthesiaOpioid Use

Outcome Measures

Primary Outcomes (2)

  • Post operative Morphone use

    Patients who received Morphine at different time points in function of the two study groups

    up to 24 hours

  • Time To Extubation (TTE)

    Time to Extubation in function of the two study groups

    Directly intraOp

Secondary Outcomes (1)

  • Post Operative Nausea and Vomiting (PONV)

    Up to 24hours

Study Arms (2)

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

Interventions

opioid anesthesiaPROCEDURE

opioid-free general anesthesia vs non opioid-free general anesthesia

Group 2 consisting of treated patients using NOFA

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients underwenting modified radical mastectomy
  • Undergoing general anesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lebanese Hospital Geitaoui-University Medical Center

Beirut, Lebanon

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 16, 2022

First Posted

January 23, 2023

Study Start

January 1, 2018

Primary Completion

September 30, 2020

Study Completion

December 1, 2020

Last Updated

January 23, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)