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Paravertebral Block for Mastectomy With Immediate Reconstruction

RecruitingNAAges 18 Years - 70 YearsFemaleCHU de Quebec-Universite Laval
NCT06276257 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the p

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18-70 years of age * woman scheduled for unilateral mastectomy with immediate reconstruction Exclusion Criteria: * Patients who will have an axillary dissection during surgery. * Woman with severe hepatic insufficiency (Child Pugh Classification B and above24). * Woman with kidney failure stage 4 and above25. * Body mass index (BMI) \> 40 kg/m2. * Woman with an allergy to local anesthetics. * Woman with a bleeding disorder in whom BPV is contraindicated. * Woman in whom stopping antiplatelet or anticoagulant therapy does not allow compliance with the standards of practice of neuraxial anesthesia issued by the American Society of Regional Anesthesia. * Woman with a single lung. * Pregnant woman.
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What it tests

  • Paravertebral block
  • Usual analgesia
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Where

1 site
CHU de Quebec - Universite Laval
Québec, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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