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临床试验/NCT06276257
NCT06276257招募中不适用

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

CHU de Quebec-Universite Laval2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Evaluation of postoperative pain using the BPI

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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 above
  • Body mass index (BMI) > 40 kg/m
  • 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.

结局指标

主要结局

Evaluation of postoperative pain using the BPI

时间窗: 24 hours, 28 hours, 72 hours after surgery

Postoperative pain will be measured using the Brief Pain Inventory (BPI)

次要结局

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

研究者

发起方
CHU de Quebec-Universite Laval
申办方类型
Other
责任方
Sponsor

研究点 (2)

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