Evaluation of Two Ultrasound-guided Techniques for Greater Occipital Nerve Injections of Local Anesthetic and Steroid for Treatment of Primary Headaches
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Numerical rating score (NRS) for headaches
研究概览
简要总结
Headache is one of the most common reasons for patients to access healthcare. Greater occipital nerve (GON) block with local anesthetic and steroid has been described for the management of primary headache refractory to conventional treatment. Two ultrasound (US)-guided techniques for greater occipital nerve (GON) block have been described for the management of refractory headache syndromes: a proximal technique performed at the level of the second cervical vertebra and a distal technique performed at the level of the superior nuchal line. Our airm is to compare the accuracy, efficacy and safety of these two techniques in patients with refractory headaches.
详细描述
We conducted a double-blinded, randomized control trial to compare accuracy, efficacy and safety of these two techniques in patients with refractory headache syndromes. Following REB approval, 40 patients with moderate or severe refractory headaches (intensity score>4/10) will be randomized to the "proximal" or "distal" groups with a 1:1 allocation. Each patient receives an injection of 2ml of 0.5% bupivacaine with 40mg of methylprednisolone. The null hypothesis is that there is no difference in intensity scores for headache at one month after the interventions. Outcomes related to efficacy (numbness immediately after the injection, reduction in episodes of severe headache, sleep quality), performance (time taken for and discomfort during procedure), and safety (incidence of hematoma, intravascular injection) are measured after one month.
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
- Single (Participant)
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
- •Features suggestive of occipital neuralgia: pain that begins in the upper neck and back of the head with radiation forward toward the eye and has an aching or burning character.
- •Diagnosis of refractory primary headache, any type
- •Baseline NRS headache score of > 4 refractory to conventional oral analgesic therapy (anti-inflammatory drugs, migraine prophylaxis and treatment drugs, opioids).
排除标准
- •Ongoing litigation issues related to the patient's pain
- •Allergy to steroids or local anesthetics
- •Multiple serious comorbidities
- •Age < 18 or age ≥ 80 years
- •GON injection within last 3 months at time of entry into the trial
研究组 & 干预措施
US-guided Distal GON Block (Group D)
Needle placement for 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg will be performed under US guidance at the level of the superior nuchal line lateral to the external occipital protuberance, close to the occipital artery.
干预措施: US-guided Greater Occipital Nerve Injection (Procedure)
US-guided Proximal GON Block (Group P)
Needle placement for 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg will be performed under US guidance at the level of the bifid C2 spinous process laterally, between the inferior obliquus capitis and semispinalis capitis muscles.
干预措施: US-guided Greater Occipital Nerve Injection (Procedure)
结局指标
主要结局
Numerical rating score (NRS) for headaches
时间窗: One month
次要结局
- Safety-Related Outcomes(Immediate post-procedure and at 1 month)
- Efficacy-Related Outcomes(24 hours and 3 months)
- Performance-Related Outcomes(During procedure)