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NCT03832920: ANIBPV
Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure
trial testing Analgesia Nociception Index in Breast Cancer in 100 participants. Completed in 1 March 2023.
26 June 2020
Quick facts
| Lead sponsor | Institut de Cancérologie de Lorraine |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 2 May 2019 |
| Primary completion | 26 June 2020 |
| Estimated completion | 1 March 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Analgesia Nociception Index
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Institut de Cancérologie de Lorraine — full company profile →
Who can join
18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Analgesia nociception index as a tool to assess the effectiveness of paravertebral block in total mastectomy: a prospective cohort study.
Raft J, Lamotte AS, Schohn CH, Fritz C, et al · · 2026 · PMID 41207559 · DOI 10.1016/j.bjane.2025.844699
Verify or expand the search:
- PubMed search for NCT03832920
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03832920 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut de Cancérologie de Lorraine
- Last refreshed: 2 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03832920.
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