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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut de Cancérologie de Lorraine (ICL)

Vandœuvre-lès-Nancy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Analgesia Nociception Index

Other

A monitor of nociception for patients under general anesthesia

Primary outcomes

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.

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)

Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups.
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

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Acronym: ANIBPV

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2023
First posted: Feb 6, 2019
Registry last updated: Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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