Status:
COMPLETED
Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure
Lead Sponsor:
Institut de Cancérologie de Lorraine
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
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. A...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03832920
Start Date
May 2 2019
End Date
March 1 2023
Last Update
January 2 2026
Active Locations (1)
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1
Institut de Cancérologie de Lorraine (ICL)
Vandœuvre-lès-Nancy, France