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

December 29, 2025 updated by: Institut de Cancérologie de Lorraine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France
        • Institut de Cancérologie de Lorraine (ICL)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

women undergo for a breast surgery with or without axillary node dissection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the ANI index
Time Frame: first minute of the surgical incision
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups.
Time Frame: Just after surgery (day 0)
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
Time Frame: Just after surgery (day 0) and the day after surgery (day 1)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: RAFT JULIEN, MD, Institut de Cancérologie de Lorraine (ICL)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2019

Primary Completion (Actual)

June 26, 2020

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

February 5, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A00121-56

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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