Breast CancerANIBPVNCT03832920
Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure
An observational study of Breast Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Analgesia Nociception Index
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2019to 1 Mar 2023
- How long will I take part?
- 26 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women undergo for a breast surgery with or without axillary node dissection
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Breast Cancer
- Being tested
- Analgesia Nociception Index
- Keywords
- general anesthesia, paravertebral Block, analgesia nociception index
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesia Nociception IndexOther
A monitor of nociception for patients under general anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the ANI index
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.
Measured: first minute of the surgical incision
Secondary outcomes (2)
Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups.
Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups.
Measured: Just after surgery (day 0)
Evaluation of pain
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
Measured: Just after surgery (day 0) and the day after surgery (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start2 May 2019
- Primary completion26 Jun 2020
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 26 Months
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RAFT JULIEN, MD, Principal investigator, Institut de Cancérologie de Lorraine (ICL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832920
- Sponsor's protocol ID
- 2019-A00121-56
- Acronym
- ANIBPV
- Status last verified
- Dec 2025
- First submitted
- 30 Jan 2019
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Raft 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.
PubMed 41207559
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure
- ClinicalTrials.gov ID
- NCT03832920
- Acronym / sponsor ID
- ANIBPV / 2019-A00121-56
- Conditions
- Breast Cancer
- Keywords
- general anesthesia, paravertebral Block, analgesia nociception index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 26 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women undergo for a breast surgery with or without axillary node dissection
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analgesia Nociception IndexA monitor of nociception for patients under general anesthesia | Other | – |
Primary outcome
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.
2 secondary outcomes
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)
Evaluation of pain
Time frame: Just after surgery (day 0) and the day after surgery (day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Results publication: PubMed 41207559Raft 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.
- Related InfoLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RAFT JULIEN, MD principal investigator
Institut de Cancérologie de Lorraine (ICL)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the ANI index (time frame: first minute of the surgical incision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03832920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.