Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Triple-Blind Randomized Crossover Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting ≥ 50% Improvement in NRS Pain Score
研究概览
简要总结
Participants with chronic, refractory phantom limb pain (PLP) or residual limb pain (RLP) for more than 6 months will be enrolled in this clinical trial. Aim: Define the attributable pain relief and functional improvement in participants with PLP/RLP after contralateral limb sciatic nerve block. Also, contribute to the basic science understanding of the crossed-withdraw reflex by demonstrating a known animal model phenomenon in human participants. Hypothesis: Contralateral limb sciatic nerve anesthetic block with 2% lidocaine provides immediate clinically meaningful pain reduction, defined as the proportion of patients with at least 50% improvement in numeric rating scale (NRS) pain score in PLP/RLP when compared to sham.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study pharmacy will prepare the study medication and it will be labeled as subject number for administration
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
- •Age greater than 18 years of age at day of enrollment
- •Lower extremity amputation performed more than 12 months before study enrollment
- •PLP/RLP in affected amputated limb > 4 on numeric rating scale 26 (NRS26)
- •Pain duration of more than 6 months despite a trial of conservative therapies for at least 2 months, including oral medications, topical medicines, physical therapy, and physical modalities (i.e., heat, cold, transcutaneous electrical nerve stimulation, phonophoresis)
- •Willingness to undergo image guided diagnostic nerve block
排除标准
- •Refusal / inability to participate or provide consent
- •Contraindications to diagnostic nerve block
- •Non-neurogenic source of PLP/RLP
- •Current opioid use > 50 morphine milligram equivalents per day
- •Any interventional pain treatment in the residual limb within the last 30 days
- •Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism)
- •Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment
研究组 & 干预措施
Treatment Group 2% Lidocaine first, then Sham Preservative Free Saline
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
Crossover: Image guided sciatic nerve anesthetic block of the contralateral limb with 10 mL preservative-free saline.
Crossover treatment will occur 5 days after the first block.
干预措施: 10 mL 2% lidocaine (Drug)
Sham Preservative Free Saline first, then Treatment Group 2% Lidocaine
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
Crossover: Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
Crossover treatment will occur 5 days after the first block.
干预措施: 10 mL preservative free saline (Drug)
结局指标
主要结局
Number of Participants Reporting ≥ 50% Improvement in NRS Pain Score
时间窗: 15 minutes after treatment
Proportions of Participants Reporting ≥ 50% Improvement in NRS pain score on a scale of 0 (no pain) to 10 (worst pain imaginable) from baseline at 15 minutes in treatment and sham groups.
次要结局
未报告次要终点