Paravertebral Block for Mastectomy With Immediate Reconstruction

Официальное название

Comparison Between Paravertebral Block and Usual Analgesia in Patients Undergoing Unilateral Total Mastectomy With Immediate Reconstruction

Обзор

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 presence of acute pain immediately postoperatively. The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure.

Вмешательства

• Процедура Paravertebral block
  An ultrasound-guided technique will be used to inject a volume of 40 mL of ropivacaine 0.2%, up to a maximum of 1.5 mg/kg, into the paravertebral space between the T3 and T4 vertebrae.
• Процедура Usual analgesia
  The patient will receive analgesia as per the anesthesiologist's preferences.

Первичные конечные точки

• Evaluation of postoperative pain using the BPI [Срок оценки: 24 hours, 28 hours, 72 hours after surgery]

Вторичные конечные точки (6)

• Total use of opioids received intraoperatively. [Срок оценки: within 3 months after surgery]
• Use of non-opioid analgesia intraoperatively [Срок оценки: During surgery]
• Total dose of opioids received in the PACU [Срок оценки: During PACU stay]
• Time before first opioid [Срок оценки: Within 3 months after surgery]
• Total opioids consumed in the 48 hours following surgery [Срок оценки: Within 48 hours after surgery]
• Chronic pain [Срок оценки: At 3 months after surgery]

Критерии участия

Критерии включения

• 18-70 years of age
• woman scheduled for unilateral mastectomy with immediate reconstruction

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Канада · 1 центр

• CHU de Quebec - Universite Laval — Québec

Идентификаторы

NCT: NCT06276257 · 2024-7301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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