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

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ClinicalTrials.gov Identifier: NCT03832920
Recruitment Status : Active, not recruiting
First Posted : February 6, 2019
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

Study Description
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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.

Condition or disease Intervention/treatment
Breast Cancer Other: Analgesia Nociception Index

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 26 Months
Official Title: Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure
Actual Study Start Date : May 2, 2019
Actual Primary Completion Date : June 26, 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Analgesia Nociception Index
    A monitor of nociception for patients under general anesthesia

Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women undergo for a breast surgery with or without axillary node dissection
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832920


Locations
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France
Institut de Cancérologie de Lorraine (ICL)
Vandœuvre-lès-Nancy, France
Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Investigators
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Principal Investigator: RAFT JULIEN, MD Institut de Cancérologie de Lorraine (ICL)
More Information
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Additional Information:

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Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT03832920    
Other Study ID Numbers: 2019-A00121-56
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Cancérologie de Lorraine:
general anesthesia
paravertebral Block
analgesia nociception index