Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFA group | Experimental | OFA (Opioid Free Anaesthesia) group: |
|
| CA control group | No Intervention | CA (Conventional Anaesthesia) control group: |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine+Lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| comparison of Morphine consumption in the two groups | during the first 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of vasopressor requirement and total intraoperative filling volume | end of surgery | |
| Assessment of the state of consciousness on arrival in the PACU | on arrival in the PACU | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patient eligible for free flap reconstruction surgery of the breastunder general anaesthesia.
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne-Claire COYNE, PhD | Contact | 0033156245765 | anne-claire.coyne@curie.fr | |
| Mary SAAD, MD | Contact | 0033147112371 | mary.saad@curie.fr |
| Name | Affiliation | Role |
|---|---|---|
| Mary SAAD, MD | Institut Curie Saint-Cloud | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Curie Paris | Recruiting | Paris | 75005 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39961716 | Derived | 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. |
Not provided
Not provided
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.
Not provided
Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Assessment of the incidence of PONV in the PACU, at D0, D1 and D2 |
| in the PACU, at D0, D1 and D2 |
| Maximum VAS at rest and mobilization in the PACU, at D0, D1 and D2 | in the PACU, at D0, D1 and D2 |
| Dose of morphine given in titration in the PACU (mg) | in the PACU |
| Number of boluses demand on PCA during the first 48 hours postoperatively | the first 48 hours postoperatively |
| DN3 score (Neuropathic Pain 3) on D2, D4, M1, M3 and M6 | on D2, D4, M1, M3 and M6 |
| Length of stay in PACU (h) and length of in-hospital postoperative length of stay (D) | at discharge |
| Assessment of the flap failure rate (flap removal surgery) and flap micro-anastomosis re-exploration rate | at discharge |
| Pain management satisfaction scores (score from 0 to 10) at discharge | at discharge |
| Collection of serious adverse events between D0 (date of surgery) and D30 | between D0 (date of surgery) and D30 |
| Dose of intraoperative rescue remifentanil in the OFA group (mcg) | at discharge |
| Morphine consumption during the first 48 hours post-operatively (mg) in each breast reconstruction subgroup (immediate and secondary); | the first 48 hours postoperatively |
| Institut Curie Saint-Cloud | Recruiting | Saint-Cloud | 92210 | France |
|
| Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | Villejuif | France |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided