Breast CancerPhase 3OFOBANCT05439005
Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
A Phase 3 study testing Dexmedetomidine in people with Breast Cancer, run by Institut Curie at 3 sites in France.
Trial summary
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 3 sitesFrance
- Study dates
- 7 Dec 2022to 6 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 or older.
- Patients with a French health insurance coverage (having a French social security number).
- Patient eligible for free flap reconstruction surgery of the breastunder general anaesthesia.
- Patient who has given written consent to participate in accordance with the regulations.
- Having a negative blood pregnancy test for patients of childbea ring age.
Who cannot join
- Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron).
- Known history of heart failure, arrhythmias and/or ischemic heart disease and/or severe renal insufficiency.
- Pulse below 50bpm during anaesthesia consultation and/or under beta blocker treatment.
- Treatment with ACEI/ARB.
- Severe asthma.
- Symptomatic gastric or duodenal ulcer with or without treatment.
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- Baseline systolic blood pressure < 100 mmHg.
- Chronic preoperative pain and/or use of WHO ladder step 2 or 3 analgesics preoperatively.
- Patient already included in another therapeutic trial evaluating an experimental molecule.
- Persons deprived of liberty or under guardianship.
- Patients with suspected difficulties in assessing pain on a scale.
- Inability to undergo trial medical monitoring due to geographic, social or psychological reasons.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Institut Curie Paris
Paris, 75005
Jane Muret, MD, jane.muret@curie.fr
jane Muret, MD
- Recruiting
Institut Curie Saint-Cloud
Saint-Cloud, 92210
Mary SAAD, MD, mary.saad@curie.fr
Mary SAAD, MD
- Recruiting
Gustave Roussy, Cancer Campus, Grand Paris
Villejuif
Migena DEMIRI, MD, migena.demiri@gustaveroussy.fr
Migena DEMIRI, MD
About this study
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
- Conditions
- Breast Cancer
- Being tested
- Dexmedetomidine
- Keywords
- free flap reconstruction surgery, anaesthesia
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine+Lidocaine
| Study group | Role | What they receive |
|---|---|---|
| OFA group | Experimental | OFA (Opioid Free Anaesthesia) group: Receives: Drug: Dexmedetomidine |
| CA control group | No intervention | CA (Conventional Anaesthesia) control group: |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of Morphine consumption in the two groups
Measured: during the first 48 hours postoperatively
Secondary outcomes (13)
Assessment of vasopressor requirement and total intraoperative filling volume
Measured: end of surgery
Assessment of the state of consciousness on arrival in the PACU
Measured: on arrival in the PACU
Assessment of the incidence of PONV in the PACU, at D0, D1 and D2
Measured: in the PACU, at D0, D1 and D2
Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2
Measured: in the PACU, at D0, D1 and D2
Dose of morphine given in titration in the PACU (mg)
Measured: in the PACU
Number of boluses demand on PCA during the first 48 hours postoperatively
Measured: the first 48 hours postoperatively
DN3 score (Neuropathic Pain 3) on D2, D4, M1, M3 and M6
Measured: on D2, D4, M1, M3 and M6
Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D)
Measured: at discharge
Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate
Measured: at discharge
Pain management satisfaction scores (score from 0 to 10) at discharge
Measured: at discharge
Collection of serious adverse events between D0 (date of surgery) and D30
Measured: between D0 (date of surgery) and D30
Dose of intraoperative rescue remifentanil in the OFA group (mcg)
Measured: at discharge
Morphine consumption during the first 48 hours post-operatively (mg) in each breast reconstruction subgroup (immediate and secondary);
Measured: the first 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start7 Dec 2022
- Primary completion6 Jun 2027 (estimated)
- Study completion6 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary SAAD, MD, Study director, Institut Curie Saint-Cloud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439005
- Sponsor's protocol ID
- IC 2021-07
- Acronym
- OFOBA
- Status last verified
- Jan 2026
- First submitted
- 27 Jun 2022
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.
Publications
Saad-Boutry M, Carton M, Ezzili C, Savignoni A. Opioid-free versus opioid-based anaesthesia for free-flap reconstruction surgery of the breast: protocol for a phase III, multicentre, randomised controlled study. BMJ Open. 2025 Feb 17;15(2):e070021. doi: 10.1136/bmjopen-2022-070021.
PubMed 39961716
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05439005
- Acronym / sponsor ID
- OFOBA / IC 2021-07
- Conditions
- Breast Cancer
- Keywords
- free flap reconstruction surgery, anaesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 6 Jun 2027 (estimated)
- Study completion
- 6 Jun 2027 (estimated)
- First posted
- 30 Jun 2022 (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.
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OFA group | Experimental | Drug: DexmedetomidineOFA (Opioid Free Anaesthesia) group: |
| CA control group | No intervention | –CA (Conventional Anaesthesia) control group: |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 18 or older.
- Patients with a French health insurance coverage (having a French social security number).
- Patient eligible for free flap reconstruction surgery of the breastunder general anaesthesia.
- Patient who has given written consent to participate in accordance with the regulations.
- Having a negative blood pregnancy test for patients of childbea ring age.
Key exclusion criteria (12 listed)
- Allergy or intolerance to any of the drugs (dexmedetomidine, remifentanil, lidocaine, propofol, dexamethasone, kétamine, ketoprofen, nefopam, paracetamol, morphine, ropivacaine, droperidol, ondansetron).
- Known history of heart failure, arrhythmias and/or ischemic heart disease and/or severe renal insufficiency.
- Pulse below 50bpm during anaesthesia consultation and/or under beta blocker treatment.
- Treatment with ACEI/ARB.
- Severe asthma.
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine+Lidocaine | Drug | OFA group |
Primary outcome
comparison of Morphine consumption in the two groups
Time frame: during the first 48 hours postoperatively
13 secondary outcomes
Assessment of vasopressor requirement and total intraoperative filling volume
Time frame: end of surgery
Assessment of the state of consciousness on arrival in the PACU
Time frame: on arrival in the PACU
Assessment of the incidence of PONV in the PACU, at D0, D1 and D2
Time frame: in the PACU, at D0, D1 and D2
Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2
Time frame: in the PACU, at D0, D1 and D2
Dose of morphine given in titration in the PACU (mg)
Time frame: in the PACU
Number of boluses demand on PCA during the first 48 hours postoperatively
Time frame: the first 48 hours postoperatively
DN3 score (Neuropathic Pain 3) on D2, D4, M1, M3 and M6
Time frame: on D2, D4, M1, M3 and M6
Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D)
Time frame: at discharge
Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate
Time frame: at discharge
Pain management satisfaction scores (score from 0 to 10) at discharge
Time frame: at discharge
Collection of serious adverse events between D0 (date of surgery) and D30
Time frame: between D0 (date of surgery) and D30
Dose of intraoperative rescue remifentanil in the OFA group (mcg)
Time frame: at discharge
Morphine consumption during the first 48 hours post-operatively (mg) in each breast reconstruction subgroup (immediate and secondary);
Time frame: the first 48 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 39961716Saad-Boutry M, Carton M, Ezzili C, Savignoni A. Opioid-free versus opioid-based anaesthesia for free-flap reconstruction surgery of the breast: protocol for a phase III, multicentre, randomised controlled study. BMJ Open. 2025 Feb 17;15(2):e070021. doi: 10.1136/bmjopen-2022-070021.
- Individual participant dataSharing planned: Yes. Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.
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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.
Mary SAAD, MD study director
Institut Curie Saint-Cloud
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine in people with Breast Cancer, run by Institut Curie at 3 sites in France.
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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Claire COYNE, PhD (0033156245765, anne-claire.coyne@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of Morphine consumption in the two groups (time frame: during the first 48 hours postoperatively). 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 NCT05439005, which also lists 1 linked publication.
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 30 Jan 2026.