Breast Cancer
Conditions
Keywords
general anesthesia, paravertebral Block, analgesia nociception index
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.
Interventions
A monitor of nociception for patients under general anesthesia
Sponsors
Institut de Cancérologie de Lorraine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the ANI index | 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
| Measure | Time frame | Description |
|---|---|---|
| Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups. | 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 | 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 |
Countries
France
Outcome results
None listed