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临床试验/NCT04317898
NCT04317898Unknown不适用

Ultrasound-Guided Serratus Plane Block Vs Paravertebral Block For Chronic Post-mastectomy Pain.

Assiut University0 个研究点目标入组 50 人开始时间: 2020年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
Percentage of patients gaining ≥ 50% pain reduction at VAS Score from baseline value.

研究概览

简要总结

compare the analgesic efficacy between ultrasound paraverbral block and serratus block in post mastectomy pain.

详细描述

It is reported that postmastectomy pain syndrome (PMPS) is a common problem, ranging from 25% to 60%.

The pain is localized in the axilla, medial upper arm, breast, and/or chest wall and lasting beyond three months after surgery when all other causes of pain such as infection have been eliminated.

The pain seriously affects the patient's mood, everyday activities, and social function and causes heavy economic burden for the healthcare system.

Postmastectomy pain syndrome (PMPS) itself is not a specific diagnosis but rather describes a cluster of symptoms frequently observed in breast cancer survivors following treatment.

Many patients will experience short-term nociceptive pain after breast cancer treatment. However, with PMPS, patients frequently experience persistent neuropathic-type pain: burning, tingling, aching, a subjective sense of "tightness" around the chest wall, or even phantom breast or nipple pain. Neuropathic pain results from dysfunction of the peripheral nerves caused by surgery, radiation, or neurotoxic chemotherapies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

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

  • Patients have postmastectomy pain of neuropathic nature, DN4
  • 4 for at least 3ms duration.
  • The intensity of postmastectomy pain on VAS score ≥
  • Unsatisfactory treatment with 1st line antineuropathic drugs, Pregabalin(150 mg daily) or Deloxetine(60mg daily).

排除标准

  • Infection of the skin at or near site of needle puncture.
  • Coagulopathy .
  • Drug hypersensitivity or allergy to the studied drugs.
  • Central or peripheral neuropthy .
  • Significant organ dysfunction .
  • Morbid obesity (BMI>35kg/m2) .
  • Vertebral anomalies.

结局指标

主要结局

Percentage of patients gaining ≥ 50% pain reduction at VAS Score from baseline value.

时间窗: baseline

Compare the analgesic efficacy between ultrasound paraverbral block and serratus block in chronic postmastectomy pain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Abo eldahab Ali elden

principal investigator

Assiut University

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