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NCT03832920: ANIBPV

Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure

Completed Last updated 2 January 2026
What this trial tests

trial testing Analgesia Nociception Index in Breast Cancer in 100 participants. Completed in 1 March 2023.

Timeline
2 May 2019
Primary endpoint
26 June 2020
1 March 2023

Quick facts

Lead sponsorInstitut de Cancérologie de Lorraine
StatusCompleted
Study typeOBSERVATIONAL
Enrollment100
Start date2 May 2019
Primary completion26 June 2020
Estimated completion1 March 2023
Sites1 location across France

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other trials of Analgesia Nociception Index

Trials testing the same drug.

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Institut de Cancérologie de Lorraine trials

Trials by the same sponsor.

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Data sources for this page

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