Clinical trial · Observational
Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Analgesia Nociception Index | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Assessment of the ANI index
- timeFrame
- first minute of the surgical incision
- description
- 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.
Secondary outcomes (2)
- measure
- Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups.
- timeFrame
- Just after surgery (day 0)
- description
- Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups.
- measure
- Evaluation of pain
- timeFrame
- Just after surgery (day 0) and the day after surgery (day 1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * American Society of Anesthesiologists score (ASA) I or II * Woman * Patients aged over 18 years * BMI between 17 and 30 kg/m2 * Radical mastectomy with or without axillary node dissection. Exclusion Criteria: * Preoperative consumption of opioid * Local Anesthesia allergy * Local skin inflammation at the puncture area * Inability to respond to pain assessment using a Numerical Rating Score (NRS) * Any contra-indication or patient's refusal for regional anesthesia B blocker medication * Pace maker * Inability to perform the PVB (at the appreciation of the anesthesiologist) * Change of surgical procedure other modified radical mastectomy with or without axillary node dissection. * Patient with a severe side effect or who cannot be controlled by additional therapy will be removed from the trial
References
Publications (1)
- RESULTRaft 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. PMID 41207559