The Role of Selective Thermal Radiofrequency Saddle Rhizotomy In Managing Interactable Malignant Perineal Pain: A Comparative Study
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 主要终点
- Change in dose of daily drug consuption
研究概览
简要总结
The control of perineal malignant pain is difficult and challenging for pain physicians. Different modalities have been tried to treat this complex pain syndrome including pharmacotherapy and interventional therapy.
Neuroaxial phenol rhizolysis is simple and cheap option. However; for patients with pelvic or rectal neoplasms and intact bowel and bladder sphincteric functions, there are neurosurgical recomendations of selective sacral nerve roots rhizotomy blockade "as an alternative to chemical saddle rhizotomy".
详细描述
40 selected patients were randomly allocated into 2 groups "20 patients each"
Group 1 "RF group": in which patients underwent thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy.
Group 2 "phenol group": in which patients underwent hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin.
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)
盲法说明
assessment will be done by junior stuff who is blind to the technique of intervention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients with moderate to severe perineal pain (VAS > 40mm over 100 mm scale).
- •Intractable pain not responding to adequate tolerated opioid therapy + adjuvant therapy after reasonable period of time for at least 4 weeks (Rad and Kallmes, 2011).
- •Limited life expectancy < 12 months (Slatakin etal 2003).
- •Patients are continent to urine and stool (no stomas).
排除标准
- •Uncorrected coagulopathy.
- •Local or systemic sepsis.
- •Known allergy to the used medications.
- •Distorted local anatomy e.g. by advanced local neoplastic growth rendering the procedure technically difficult or hazardous.
- •Sign of increased intracranial tension (Mintzer and Devarajan, 2012).
研究组 & 干预措施
Thermal Radiofrequency group
Group 1 "RF group": in which patients will receive thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy.
干预措施: Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy (Procedure)
Thermal Radiofrequency group
Group 1 "RF group": in which patients will receive thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy.
干预措施: Thermal RF lesioning is done using Bailys RF generator (Device)
phenol group
Group 2 "phenol group": in which patients will recieve hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin.
干预措施: hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin) (Drug)
结局指标
主要结局
Change in dose of daily drug consuption
时间窗: base line, one month, 3 months
drug (opioid, pregabalin \& amitryptiline) consumption (mg/day) .
Functional improvement
时间窗: baseline, one month, 3 months
Functional improvement. It is a self-reported analysis for the primary outcome after performing pain interventions. It is divided into four categorie (0-25%) ≈ no or minimal functional improvement, (\> 25% to 50%) ≈ mild improvement, (\>50% to 75%) ≈ moderate improvement, and (\>75% to 100%) ≈ marked improvement
Change in VAS
时间窗: baseline, one month, 3months
VAS: A 100mm scale, horizontal line with 2 stop ends; the left end means no pain \& the right end means the worst impaginable pain. It is a valid and practical scale for assessing chronic pain and for pain researches.
次要结局
- ODI(baseline, one month, 3 months)
- PGIC(baseline, one month and 3 months)
研究者
Dina Nabil Abbas
Assistant professor of anethesia and pain management
Cairo University