SurgeryNCT05693402

Opioid-Free Anesthesia in Modified Radical Mastectomy

An observational study of Surgery and Anesthesia, run by Etienne El Helou at 1 site in Lebanon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Any age, women only
Conditions the study is for: Surgery, Anesthesia, Opioid Use
What is being tested?: opioid anesthesia
Type of treatment: Surgery or procedure
How many people: 116 participants
Where: 1 siteLebanon
Study dates: 1 Jan 2018to 1 Dec 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

Patients underwenting modified radical mastectomy
Undergoing general anesthesia

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Lebanon1 site

Lebanese Hospital Geitaoui-University Medical Center
Beirut

Other trials in Lebanon

About this study

Official title: 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.

Conditions: Surgery, Anesthesia, Opioid Use
Being tested: opioid anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

opioid anesthesiaProcedure or surgery
opioid-free general anesthesia vs non opioid-free general anesthesia

Study groups in NCT05693402
Study group	Role	What they receive
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) Receives: Procedure: opioid anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20181 Dec 2020

First posted23 Jan 2023
Study start1 Jan 2018
Primary completion30 Sep 2020
Study completion1 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05693402
Sponsor's protocol ID: HelouAssaf
Status last verified: Jan 2023
First submitted: 16 Dec 2022
Last updated: 23 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Opioid-Free Anesthesia in Modified Radical Mastectomy
ClinicalTrials.gov ID: NCT05693402
Acronym / sponsor ID: HelouAssaf
Conditions: Surgery, Anesthesia, Opioid Use
Study type: Observational
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Etienne El HelouUniversity, hospital or other
Study start: 1 Jan 2018 (actual)
Primary completion: 30 Sep 2020 (actual)
Study completion: 1 Dec 2020 (actual)
First posted: 23 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
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	–	Procedure: opioid anesthesiaGroup 2 consisted of 60 patients (Mean age was 51±12 years)

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Between January 2018 and September 2020, data from admitted patients for modified radical mastectomy under general anesthesia were enrolled.

Key inclusion criteria (2 listed)

Patients underwenting modified radical mastectomy
Undergoing general anesthesia

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
opioid anesthesiaopioid-free general anesthesia vs non opioid-free general anesthesia	Procedure or surgery	Group 2 consisting of treated patients using NOFA

Primary outcome

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
Time To Extubation (TTE)
Time frame: Directly intraOp
Time to Extubation in function of the two study groups

1 secondary outcome

Post Operative Nausea and Vomiting (PONV)
Time frame: Up to 24hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
Individual participant dataSharing planned: No

Related trials for Surgery

Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
Thoracic, Surgery
Active, not recruiting
Prevalence and Clinical Impact of Airway Opening Pressure in Post-Cardiac Surgery Patients
Cardiac Surgery, Mechanical Ventilation After Surgery
RecruitingObservational study
Bariatric Surgery and Gut Microbiota Changes Over Time
Obese Patients, Obese Patients With Bariatric Surgery
Not yet recruitingPhase 4
Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery
Heart Failure, Cardiac Surgery

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery and Anesthesia, run by Etienne El Helou at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post operative Morphone use (time frame: up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05693402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.