Evaluation of Post Mastectomy Pain Syndrome After Preoperative Stellate Ganglion Block for Breast Cancer Surgeries, Clinical Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of Neuropathic pain Syndromes
研究概览
简要总结
This study investigate the effect of pre-operative ultrasound guided stellate ganglion block with local anesthetic on the frequency of neuropathic pain syndromes in the first 6-month post cancer breast surgeries with axillary dissection.
详细描述
In this study Eighty Female patients with a diagnosis of breast cancer, underwent breast surgery with axillary dissection at National Cancer Institute, Cairo University were included in this study. Patients will be randomized into two equal comparable groups of patients.
(Group A the study group) was received pre-operative ultrasound guided stellate ganglion block one hour before surgery and multimodal analgesia and (Group B the control group) was received multimodal analgesia only.
The present study showed in regards to the acute pain management of the stellate ganglion block: intraoperative hemodynamics, mean arterial blood pressure and heart rate (MABP, HR) were statistically significant less in group A (Stellate Group) than group B (Control Group) and this leads to significant less opioid consumption in Group A (Stellate Group) than Group B (Control group). In the 1st 24h postoperative opioid consumption measured by number of rescue dose of morphine 5mg IV were administered when visual analogue score was more than 4 and total requirement per 24 hours was recorded. The results show statistically significant less opioid consumption in Group A (Stellate Group) with average visual analogue score 3.5 in 1st 24h than Group B (Control group) with average visual analogue score 5.5 in 1st 24h.
The present study showed in regards to the chronic pain management of the stellate ganglion block that, the 6-month relative frequency of neuropathic pain syndromes, using the grading system for neuropathic pain (GSNP) shows statistically significance lower frequency of neuropathic pain syndromes in Group A (Stellate Group) than Group B (Control group).
Assessment of patient daily activity and functional capacity using Eastern cooperative oncology group (ECOG) scoring showed statistically significance higher performance status (lower numbers in the score) in Group A (Stellate Group) than Group B (Control group).
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women were eligible if a diagnosis of breast cancer, programmed for breast surgery with axillary dissection, able to understand and willing to follow the study protocol
排除标准
- •Patient refusal - Local infection at the site of injection - Allergy to study medications - Psychosocial disorders - pts on opioid or antianxiety - Sepsis - Anatomic abnormalities - Systemic anticoagulation or coagulopathy - Inability to comprehend or participate in pain scoring system - Recent myocardial infarction - Pathological bradycardia - Glaucoma
- •Any contraindication for the multimodal analgesia e.g. (asthmatic patient and use of diclofenac, Diabetic patient and use of steroids)
研究组 & 干预措施
Stellate Group
will receive pre-operative ultrasound guided stellate ganglion block one hour before surgery and multimodal analgesia and will be followed for 6 months for neuropathic pain as the Stellate Group
干预措施: Stellate Ganglion Block (Procedure)
Stellate Group
will receive pre-operative ultrasound guided stellate ganglion block one hour before surgery and multimodal analgesia and will be followed for 6 months for neuropathic pain as the Stellate Group
干预措施: Multimodal Analgesia (Drug)
Control Group
will receive multimodal analgesia only and will be followed for 6 months for neuropathic pain as the control Group
干预措施: Multimodal Analgesia (Drug)
结局指标
主要结局
Incidence of Neuropathic pain Syndromes
时间窗: 6 months after surgery
relative frequency of neuropathic pain syndromes post breast surgeries with axillary dissection after preoperative ultrasound stellate ganglion block. This is accomplished using the grading system for neuropathic pain (GSNP),0: No Pain,1: Pain, 2: Possible neuropathic: Pain with (A history of relevant neurological lesion or disease AND Pain distribution neuroanatomically plausible, 3: Pain Probable neuropathic: Positive sensory signs (allodynia, hyperalgesia, electric, burning, numbness, itching, maybe motor or autonomic changes) on the distribution of the injured nerves or beyond, 4: Pain Definitive neuropathic: diagnostic test confirms the lesion or disease of the somatosensory nervous system OR a surgeon's clear verification of an intraoperative nerve lesion (intercostobrachial in MRM with Axillary Evacuation in Breast Surgery)
patient daily activity and functional capacity
时间窗: 6 months after surgery
Assessment of patient daily activity and functional capacity is evaluated using Eastern cooperative oncology group "ECOG" scoring, (0=fully active, 1= able to perform light effort, 2= in bed \<50% of the day 3=in bed \>50% of the day, 4=bed ridden, 5=died) so the low score the better.
次要结局
- opioid consumption(Post-operative 24 hours)
研究者
Ahmed Salman Solyman Salman
Aneasthetist
National Cancer Institute, Egypt