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临床试验/NCT02641951
NCT02641951Unknown不适用

Stellate Ganglionic Block Versus Combined Stellate Ganglionic Block and Modified Pectoral Nerve Block in Treatment of Post Mastectomy Pain Syndrome.

Mansoura University0 个研究点目标入组 40 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Pain scores

研究概览

简要总结

Post mastectomy pain syndrome result from surgical damage to the intercostobrachial nerve, the lateral cutaneous branch of the second intercostal nerve that is often resected at mastectomy. result from surgical damage to the intercostobrachial nerve, the lateral cutaneous branch of the second intercostal nerve that is often resected at mastectomy, A second version of the pectoral nerve block is described, called ''modified Pecs block'' or Pecs block type II.

This novel approach aims to block at least the pectoral nerves, the intercostobrachial, intercostals III-IV-V-VI and the long thoracic nerve. These nerves need to be blocked to provide complete analgesia during breast surgery

详细描述

The aim of this study is to evaluate the efficacy of ultrasound guided stellate ganglionic block alone versus stellate ganglionic block plus pecs II block in management of chronic postmastectomy pain ,patient will be trained to use visaual analog scale to describe their pain range of movement will be assessed using manual geniometry at post procedure visits at one month ,3 months and 6 months procedures in each group will done using ultrasound guidance mixture will be used.

All patients will be informed about the procedure and its possible consequences after detailed explanation of protocol of this study. Written informed consents will be obtained before the procedure.

With each block, an intravenous cannula will be inserted and secured. All suitable resuscitation equipment and drugs will be available. Vital signs (heart rate, blood pressure, and oxygen saturation) will be monitored throughout the procedure and up to 1 hour after the block performance. Midazolam 0.02 ug/kg will be administered intravenously as premedication.

Brief evaluation will be done for all patients with regard to their systemic diseases, general condition, and coagulation status.

All patients will be familiar with the use of 10-cm visual analogue scale score (VAS) identifying 0 as no pain and 10 as worst imaginable pain.Basal assessment of range of movement for abduction ,external rotation ,and forward flextion using manual geniometry and patients will be asked to complete Quality of life questionnaire

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

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

  • American Society of Anesthesiologists physical status III or IV.
  • Patients having irradiating pain of anterior chest wall and axilla after breast surgery.
  • Patients having irradiating pain of ipsilateral arm after breast surgery
  • Pain not responding to conservative treatment
  • Pain persisting for more than 3 month

排除标准

  • Local skin infection
  • Coagulation or blood disease
  • Pregnancy
  • Postpartum or lactating females
  • Allergy to the study medications.
  • Severely altered consciousness level.
  • Psychiatric disorder
  • Drug abuse
  • Spine or chest wall deformities

结局指标

主要结局

Pain scores

时间窗: for six months after the procedure

100 mm- visual analog pain scale

次要结局

  • The range of motion of the glenohumeral joint(for six months after the procedure)
  • The quality of life score(for six months after the procedure)

研究者

申办方类型
Other
责任方
Sponsor

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