Clinical trial NCT03832920: Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure
Official title: Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: general anesthesia
paravertebral Block
analgesia nociception index
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women undergo for a breast surgery with or without axillary node dissection

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.


Eligibility 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

Primary outcomes:
measure: Assessment of the ANI index
timeFrame: first minute of the surgical incision
Secondary outcomes:
measure: Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups.
timeFrame: Just after surgery (day 0)
measure: Evaluation of pain
timeFrame: Just after surgery (day 0) and the day after surgery (day 1)
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine (ICL)
Study officials:
affiliation: Institut de Cancérologie de Lorraine (ICL)
name: RAFT JULIEN, MD
role: PRINCIPAL_INVESTIGATOR
References: