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

NCT03832920 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-01-02

No results posted yet for this study

Summary

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

Interventions

OTHER

Analgesia Nociception Index

A monitor of nociception for patients under general anesthesia

Sponsors & Collaborators

  • Institut de Cancérologie de Lorraine

    lead OTHER

Principal Investigators

  • RAFT JULIEN, MD · Institut de Cancérologie de Lorraine (ICL)

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2020-06-26
Completion
2023-03-01

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03832920 on ClinicalTrials.gov