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Paravertebral Block (PVB) combined with general anesthesia (GA) is a conventional pain treatment for breast surgery but sometimes failures can occurs. The efficacy of this block has to be evaluated. Also, for the intra-operative analgesic evaluation of this block, it is necessary to measure intra-operative analgesia index. A monitor of nociception for patients under GA, the PhysiodolorisTM device, offers an index for measuring nociceptive inputs during surgery in anesthetized patients : the ANI index (based on the single R-R interval analysis). The purpose of this observational and prospective study is to assess the variations of this ANI index during breast surgery with or without axillary node dissection with a PVB. This will allow us to quantify the analgesic effect of a PVB during GA for unilateral radical breast surgery with or without axillary node dissection.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analgesia Nociception Index | Other | A monitor of nociception for patients under general anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the ANI index | Assessment of the area under the curve of the variation of the ANI index for the first minute of the surgical incision according to the PVB failure: incomplete or ineffective vs effective. The PVB failure will be evaluate with a cold test on the thoracic levels T2 and T6. | first minute of the surgical incision |
| Measure | Description | Time Frame |
|---|---|---|
| Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups. | Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups. | Just after surgery (day 0) |
| Evaluation of pain |
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Inclusion Criteria:
Exclusion Criteria:
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women undergo for a breast surgery with or without axillary node dissection
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| Name | Affiliation | Role |
|---|---|---|
| RAFT JULIEN, MD | Institut de Cancérologie de Lorraine (ICL) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de Lorraine (ICL) | Vandœuvre-lès-Nancy | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41207559 | Result | Raft J, Lamotte AS, Schohn CH, Fritz C, Richebe P. Analgesia nociception index as a tool to assess the effectiveness of paravertebral block in total mastectomy: a prospective cohort study. Braz J Anesthesiol. 2026 Jan-Feb;76(1):844699. doi: 10.1016/j.bjane.2025.844699. Epub 2025 Nov 7. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Evaluation of the Numerical Rating Score (NRS) (no pain = 0, worst pain =10): NRS at arrival in the post anesthesia care unit , NRS at leaving of the post anesthesia care unit and at the postoperative day 1. NRS will be compare according to the PVB failure |
| Just after surgery (day 0) and the day after surgery (day 1) |
| D017437 |
| Skin and Connective Tissue Diseases |