Comparative evaluation of superior hypogastric plexus block via ultrasound guided versus fluoroscopy guided in patients with pelvic malignancies
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To compare decrease in pain as assessed by change in visual analog scale score by ultrasound guided anterior approach versus fluoroscopy guided posterior approach of Superior Hypogastric Plexus neurolysis in patients with pelvic pain due to malignancies.
研究概览
简要总结
Simple randomization using simple enumerated sampling method .After obtaining the institutional ethical committee approval and written informed consent from the participants, they will be enrolled into our study.
A total of participants will be enrolled and randomized into two equal groups of each . i.e 28 in each group.
Group A : chronic pelvic pain patients receiving USG guided superior hypogastric plexus block with 2-3 milliliters of 0.25% bupivacaine + 5ml of 70% alcohol
Group B : chronic pelvic pain patients receiving fluoroscopy guided superior hypogastric plexus block with 2-3 milliliters of 0.25% bupivacaine + 5ml of 70% alcohol
The patients instructed prior to the scheduled procedure regarding how to evaluate pain by using visual analog pain scale (0=no pain, 10= maximum pain imaginable)
After which the following primary & secondary objectives will be assessed accordingly.
PRIMARY OBJECTIVE
To compare decrease in pain as assessed by change in visual analog scale score by ultrasound guided anterior approach versus fluoroscopy guided posterior approach of Superior Hypogastric Plexus neurolysis in patients with pelvic pain due to malignancies.
SECONDARY OBJECTIVE
To assess the feasibility of the procedures - time taken & patients comfort
To assess the complications associated with the two techniques
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with pelvic pain secondary to malignancy of either sex, in the age group of 30-65 years and American Society of Anaesthesiologists (ASA) grade II & III will be included in the study.
排除标准
- •Patient having chronic pelvic pain due to nonmalignant conditions ASA Grade IV patients & Extra pelvic metastases Patients with coagulopathy Patients allergic to the study drugs.
结局指标
主要结局
To compare decrease in pain as assessed by change in visual analog scale score by ultrasound guided anterior approach versus fluoroscopy guided posterior approach of Superior Hypogastric Plexus neurolysis in patients with pelvic pain due to malignancies.
时间窗: Preprocedure | Postprocedure - immediate,1 week,1 month,2 months
次要结局
- To assess the feasibility of the procedures - time taken & patients comfort(To assess the complications associated with the two techniques)
研究者
Revanth S
Institute of medical sciences Banaras Hindu University Varanasi