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

NCT03832920 | Completed

• 1 other identifier: 2019-A00121-56
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

general anesthesia; paravertebral Block; analgesia nociception index

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Just after surgery (day 0)

• Evaluation of pain

  Just after surgery (day 0) and the day after surgery (day 1)

Interventions

Analgesia Nociception Index OTHER

A monitor of nociception for patients under general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancérologie de Lorraine (ICL)

Vandœuvre-lès-Nancy, France

Location

Related Publications (1)

• 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.

  PMID: 41207559 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• RAFT JULIEN, MD

  Institut de Cancérologie de Lorraine (ICL)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 26 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 6, 2019
• Study Start: May 2, 2019
• Primary Completion: June 26, 2020
• Study Completion: March 1, 2023
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

FR (1)