Comparison of the Efficacy of the Ultrasound With Fluoroscopy in Guidance of Lumbar Sympathetic Block: A Prospective Randomized Open-label Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Difference in Procedure time (I1)
研究概览
简要总结
This study compares the efficacy of the ultrasound with fluoroscope in guidance of lumbar sympathetic block (LSB). The goals of the study are; 1) To show that US-guided LSB results in shorter performance time compared to fluoroscope-guided LSB, 2) To evaluate the efficacy and safety of US-guided LSB, and 3) To verify that US-guided LSB has similar success rates to fluoroscope-guided LSB. 50 patients who are supposed to undergo LSB due to sympathetically maintained pain, satisfy criteria of inclusion and exclusion, and voluntarily sign the informed consent will be enrolled.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have sympathetically-mediated pain and are supposed to undergo LSB procedure (e.g. pain with asymmetric skin temperature of lower limb in previous thermography, small fiber disorder in previous quantitative sudomotor axon reflex test (QSART), vascular insufficiency in lower extremities, diabetic polyneuropathy, postherpetic neuralgia, complex regional pain syndrome, cancer-related neuropathic pain such as chemotherapy-induced peripheral neuropathy, other lower extremity neuropathies, lower extremity crush injury etc.)
- •Numeric rating scale (NRS) ≥ 4/10
- •Failure of previous conservative treatments, such as physiotherapy, oral medication, or other noninvasive treatment
排除标准
- •Previous lumbar sympathetic neurolysis
- •Bleeding tendency
- •Local infection
- •Allergy to local anesthetics or contrast media
- •Pregnancy
- •Severe variation near procedure site-scoliosis, tumor, abdominal aneurysm, etc.
- •BMI ≥ 30 kg/m2
- •Cognitive dysfunction
研究组 & 干预措施
Ultrasound with Fluoroscope
This group undergoes lumbar sympathetic block using ultrasound and fluoroscope.
Preparation: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Ultrasound for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB
干预措施: 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) (Device)
Ultrasound with Fluoroscope
This group undergoes lumbar sympathetic block using ultrasound and fluoroscope.
Preparation: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Ultrasound for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB
干预措施: Ultrasound for Lumbar Sympathetic Block (LSB) (Device)
Ultrasound with Fluoroscope
This group undergoes lumbar sympathetic block using ultrasound and fluoroscope.
Preparation: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Ultrasound for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB
干预措施: 10 ml of 0.25% levobupivacaine injection for LSB (Drug)
Ultrasound with Fluoroscope
This group undergoes lumbar sympathetic block using ultrasound and fluoroscope.
Preparation: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Ultrasound for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB
干预措施: Temperature measurement for Lumbar Sympathetic Block (LSB) (Procedure)
Ultrasound with Fluoroscope
This group undergoes lumbar sympathetic block using ultrasound and fluoroscope.
Preparation: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Ultrasound for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB
干预措施: Postprocedure care for LSB (Procedure)
Fluoroscope only
This group undergoes lumbar sympathetic block using fluoroscope only.
Device: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Fluoroscope for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB
干预措施: 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) (Device)
Fluoroscope only
This group undergoes lumbar sympathetic block using fluoroscope only.
Device: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Fluoroscope for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB
干预措施: Fluoroscope for Lumbar Sympathetic Block (LSB) (Device)
Fluoroscope only
This group undergoes lumbar sympathetic block using fluoroscope only.
Device: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Fluoroscope for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB
干预措施: 10 ml of 0.25% levobupivacaine injection for LSB (Drug)
Fluoroscope only
This group undergoes lumbar sympathetic block using fluoroscope only.
Device: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Fluoroscope for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB
干预措施: Temperature measurement for Lumbar Sympathetic Block (LSB) (Procedure)
Fluoroscope only
This group undergoes lumbar sympathetic block using fluoroscope only.
Device: Inserts 24G intravenous route for Lumbar Sympathetic Block (LSB) Device: Uses 15-cm Chiba needle for Lumbar Sympathetic Block (LSB) Device: Uses Fluoroscope for Lumbar Sympathetic Block (LSB) Drug: 10 ml of 0.25% levobupivacaine injection for LSB Intervention: Temperature measurement for Lumbar Sympathetic Block (LSB) Intervention: Postprocedure care for LSB
干预措施: Postprocedure care for LSB (Procedure)
结局指标
主要结局
Difference in Procedure time (I1)
时间窗: through the LSB procedure completion (day 0)
U group: the time interval between the contact of the US probe with the patient's skin and the completion of the injection of levobupivacaine F group: the time interval between the first radiographic image and the end of the injection of levobupivacaine
次要结局
- Success rate(through the LSB procedure completion (day 0))
- Onset time of block (I2)(through the LSB procedure completion (day 0))
- Changes of an 11-pointed NRS pain score from baseline for their lower extremity pain(performs telephone follow-up in 72 hours.)
- The number of the needle contact to bone during the procedure(through the LSB procedure completion (day 0))
- Spreading pattern of contrast dye during the procedure(through the LSB procedure completion (day 0))
- An 11-pointed NRS pain score related to the procedure only(through the LSB procedure completion (day 0))
- Any adverse events(Up to 72 hours after the procedure)
- The number of needle passes(through the LSB procedure completion (day 0))
- Procedure-related NRS pain score(performs telephone follow-up in 72 hours.)
- Changes of dose in analgesics(performs telephone follow-up in 72 hours.)
- Any adverse events remained(performs telephone follow-up in 72 hours.)
- A 5-pointed Likert satisfaction scale related to the procedure(performs telephone follow-up in 72 hours.)
研究者
Jeeyoun Moon
Clinical Associate Professor
Seoul National University