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Opioid-Free Anesthesia in Modified Radical Mastectomy

Sponsor
Etienne El Helou (Other)
Overall Status
Completed
CT.gov ID
NCT05693402
Collaborator
(none)
116
Enrollment
1
Location
35
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: opioid anesthesia

Study Design

Study Type:
Observational
Actual Enrollment :
116 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Efficacy of Opioid-Free Anesthesia in Modified Radical Mastectomy
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Post operative Morphone use [up to 24 hours]

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

  2. Time To Extubation (TTE) [Directly intraOp]

    Time to Extubation in function of the two study groups

Secondary Outcome Measures

  1. Post Operative Nausea and Vomiting (PONV) [Up to 24hours]

    Patients who had PONV at different times in function of the two study groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lebanese Hospital Geitaoui-University Medical Center Beirut Lebanon

Sponsors and Collaborators

  • Etienne El Helou

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Etienne El Helou, Principal investigator, Dr Etienne El Helou
ClinicalTrials.gov Identifier:
NCT05693402
Other Study ID Numbers:
  • HelouAssaf
First Posted:
Jan 23, 2023
Last Update Posted:
Jan 23, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Analgesics, Opioid
Anesthetics

Study Results

No Results Posted as of Jan 23, 2023