The Feasibility of Local Anesthesia for Bilateral Orchiectomy : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- intraoperative pain score
研究概览
简要总结
The goal of this randomized controlled trial is to compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications between SA and SCB groups in metastatic prostate cancer patient. The main question it aims to answer are:
• Is there a difference in the level of pain during bilateral orchiectomy between spinal anesthesia and spermatic cord block?
Participants will undergo bilateral orchidectomy. They will be randomly assigned to two groups: the group receiving spinal anesthesia and the group receiving spermatic cord block If there is a comparison group: Researchers will compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications in both groups of patients.
详细描述
Objective : To compare intraoperative pain score, Morphine consumption during 6 and 12 hour after surgery, and postoperative complications between SA and SCB groups.
Material and Method : This Randomized Controlled Trial that collected data from prostate cancer patients who underwent orchiectomy in our institution. Patients were randomly divided into two groups; SA and SCB. Data was collected on intraoperative pain score, 1 hour post-surgery, Morphine consumption during 6 and 12 hour after surgery and complications. All data was statistically analyzed using Independent t-test and Fisher's exact test.
Inclusion criteria : Patients of all ages diagnosed with prostate cancer undergoing treatment with bilateral orchiectomy.
Exclusion criteria :
- Patients with a history of Xylocaine allergy.
- Patients with uncorrected bleeding disorders.
- Patients with paralysis or neurosensory deficits
- Patients with dementia or cerebrovascular accidents (strokes) that impair communication.
- Patients with contraindications for spinal anesthesia, including:
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
- Single (Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients of all ages diagnosed with prostate cancer undergoing treatment with bilateral orchiectomy
排除标准
- •Patients with a history of Xylocaine allergy.
- •Patients with uncorrected bleeding disorders.
- •Patients with paralysis or neurosensory deficits
- •Patients with dementia or cerebrovascular accidents (strokes) that impair communication.
- •Patients with contraindications for epidural anesthesia, including:
- •Patient refusal of spinal anesthesia.
- •Infection at the site of spinal injection.
- •Allergy to specific types of local anesthetics, such as Hyperbaric bupivacaine.
- •Inability of the patient to cooperate with the spinal anethetic procedure.
- •Suspicion of high intracranial pressure based on abnormal physical examination.
- •Aortic stenosis with fixed cardiac output.
- •Low platelet count.
研究组 & 干预措施
Spinal anesthesia
spinal anesthesia : 0.5%hyperbaric bupivacaine 10-15 mg/dose injected at L3-L5
干预措施: bilateral orchiectomy (Procedure)
spermatic cord block
1%Xylocaine with adrenaline (Max 7 mg/kg/dose) divided to inject into each side of the spermatic cord 6-8 ml and infiltration into the scrotal incision area 3-4 ml.
干预措施: bilateral orchiectomy (Procedure)
结局指标
主要结局
intraoperative pain score
时间窗: Immediate postoperative assessment
Pain assessment is done using the verbal numerical rating scale, where patients rate their pain level from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable, without using any materials or equipment.
次要结局
- post-operative pain score(1 hour after surgery)
- morphine consumption(during 6 and 12 hour after surgery)
- post-operative complications(24 hour after surgery)
研究者
Thararat Wanthawong
Principal Investigator of Urology department, Sunpasitthiprasong hospital, Ubonratchathani, Thailand
Sanpasitthiprasong Hospital