Efficacy of Adding Lidocaine 10% to Phenol in Ultrasound Guided Superior Hypogastric Plexus Neurolysis in The Management of Pelvic Cancer Pain
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 主要终点
- : NRS
研究概览
简要总结
The superior hypogastric plexus (SHP) is a complex nervous collection located at the lumbosacral region below the level of the aortic bifurcation at the level of the lower third of the fifth lumbar vertebral body and upper third of the first sacral vertebral body at the sacral promontory Neurolytic agents, such as alcohol and phenol have been used to ablate peripheral nerves to treat pain and spasticity . These agents were nonspecific for neuronal tissue and complications have been seen involving damage to surrounding soft tissue (skin, muscle, vascular) and pain on alcohol injection
Lidocaine has been demonstrated to be neurotoxic in high concentrations at 10% and can be used as a neurolytic agent with no effect on motor function, muscle state, or surrounding tissue rather than other neurolytic.
详细描述
Every Patient will be in supine Trendelenburg position, IV access in case of adverse events and for moderate sedation if needed (for patient comfort, sever anxiety or needle phobia, or history of vagal events).
The procedure will be completed under aseptic precautions. The division of abdominal aorta into common iliac arteries will be identified by using longitudinal sonography (Lumify L12-4 Linear Array Transducer 12 to 4 MHz extended operating frequency range, 34mm footprint and aperture size, and scan depth of up to 12cm. Imaging modes include 2D, color Doppler, and M-mode), and the body of the fifth (5th) Lumbar vertebra will be identified by placing the transducer transversely. A skin wheal will be raised with subcutaneous infiltration with 2% lidocaine solution nearly 3-4 cm below the umbilicus. A 15-cm Long 22-G Chiba needle will be used with out of plane technique, and the needle will be advanced under USG-guidance to reach the anterior- most point of the fifth Lumber vertebral body avoiding the vascular structures. The needle will be withdrawn nearly 1-2 mm after hitting the vertebral body to avoid injecting the drug into the periosteum. After confirming a negative aspiration of blood, known amount of neurolytic agent according to the grouping will be injected for the neurolysis of superior hypogastric plexus. The uniform spread of the drug will be confirmed under real-time sonography. Vital Sign parameters will be recorded during and after the procedure, during which patients remained fully awake
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients more than 18 years old.
- •Either genders.
- •Cancer-related pelvic pain.
- •American Society of Anesthesiologists Physical Status class I and II.
- •Patients receiving opioids for pelvic cancer pain with visual analogue pain scale more than
- •BMI < 30.
排除标准
- •. patient refusal. local or systemic sepsis. Coagulopathy. unstable cardiovascular and respiratory diseases. previous neurological deficits, history of psychiatric disorders history of drug abuse distorted local anatomy. allergy to the used medications.
结局指标
主要结局
: NRS
时间窗: after 1 week from block
from 0 to 10 (0= no pain ,10 =maximum pain)
NRS
时间窗: after 3 month from block
from 0 to 10 (0= no pain ,10 =maximum pain)
次要结局
- Patient satisfaction(after injection)
- daily analgesic requirements(after 3 months from injection)
- side effect during injection(during injection)
研究者
Nevert Adel
assist. prof. of anesthesia and pain management
Mansoura University