跳至主要内容
临床试验/NCT05732532
NCT05732532已完成4 期

Treatment of Headache With Occipital Nerve Blocks: Comparison Trial of Anesthetic With or Without Dexamethasone

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年2月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Mayo Clinic
入组人数
120
试验地点
1
主要终点
Change in Headache Days 4 Weeks Following Treatment

研究概览

简要总结

Currently there is limited evidence of benefit for the addition of steroids to occipital nerve blocks for treatment of headache, and not all steroids have been explored. The purpose of this research is to learn more about whether the addition of a specific kind of steroid (dexamethasone) provides any additional benefit to nerve blocks.

详细描述

Patients who are referred by their neurology provider for occipital nerve block as treatment of headache according to current accepted standard of care will be considered for this study. Baseline data will be obtained from the patients prior to proceeding with their nerve block and their headache diagnosis will be recorded based on electronic medical record review. Patients will be randomized to one of two treatment arms, anesthetic with dexamethasone or anesthetic without dexamethasone. The injectate will be the same color and amount of solution for each trial arm. Thus, the neurology provider performing the injection remains blinded and the patient remains blinded.

Injection sites will be inspected to ensure no active bleeding, infection, cranial bone or cervical spine defects/prior surgeries that prohibit safe use of landmark-based technique. A neurologist who is experienced at performing nerve blocks will administer the injections to the bilateral greater and lesser occipital nerves using the landmark-based technique. The occipital protuberance and mastoid process are palpated, with the location of the greater occipital nerve at approximately 1/3 the distance laterally and the lesser occipital nerve at approximately 2/3 the distance laterally along the nuchal ridge for a total of 4 injection sites.

Patients will be observed for approximately 10 minutes after the procedure to monitor for any immediate adverse effects and to ensure that anesthesia in the distribution of the injected nerves was achieved. Then, they will be instructed to keep a headache diary after treatment and will be provided a written example diary. A study staff who remains blinded to the patient's trial arm (but not necessarily the neurology provider who performed the injection) will contact the patients via telephone at 1, 2 and 4 weeks to assess response to treatment.

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
Double (Participant, Investigator)

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

  • •Treated for headache including but not limited to occipital neuralgia, episodic migraine, chronic migraine and/or cervicogenic headache.
  • •Stable on preventative medication dosing for at least 1 month prior to occipital nerve block and no change in preventative medication regimen during the course of the study.
  • •Able to understand the requirements of the study and return for treatment.
  • •Able to independently provide informed consent.

排除标准

  • •Diagnosis of cluster headache according to the International Classification of Headache Disorders 3rd edition.
  • •Occipital or other cranial nerve block administered within 3 months prior to initiation of study.
  • •History of adverse reaction or contraindication to any of the study ingredients (bupivacaine, lidocaine, dexamethasone).
  • •Pregnancy.
  • •Infection or bleeding at site of injection.
  • •Cranial bone or cervical spine defects/prior surgeries near injection site that prohibit use of landmark-based technique.

研究组 & 干预措施

Anesthetic without steroid group

Active Comparator

Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and normal saline.

干预措施: Normal saline (Drug)

Anesthetic without steroid group

Active Comparator

Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and normal saline.

干预措施: Greater/lesser occipital nerve blocks (Procedure)

Anesthetic with dexamethasone group

Experimental

Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and dexamethasone.

干预措施: Greater/lesser occipital nerve blocks (Procedure)

Anesthetic without steroid group

Active Comparator

Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and normal saline.

干预措施: Lidocaine (Drug)

Anesthetic without steroid group

Active Comparator

Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and normal saline.

干预措施: Bupivacaine (Drug)

Anesthetic with dexamethasone group

Experimental

Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and dexamethasone.

干预措施: Bupivacaine (Drug)

Anesthetic with dexamethasone group

Experimental

Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and dexamethasone.

干预措施: Lidocaine (Drug)

Anesthetic with dexamethasone group

Experimental

Subjects scheduled for bilateral greater/lesser occipital nerve blocks as part of clinical care will receive standard of care medication, including lidocaine and bupivacaine and dexamethasone.

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Change in Headache Days 4 Weeks Following Treatment

时间窗: Baseline; 4 weeks

The change in the number of self-reported days subjects experienced headaches from baseline to 4 weeks.

Change in Headache Days 1 Week Following Treatment

时间窗: Baseline; 1 week

The change in the number of self-reported days subjects experienced headaches from baseline to 1 week.

Change in Headache Days 2 Weeks Following Treatment

时间窗: Baseline; 2 weeks

The change in the number of self-reported days subjects experienced headaches from baseline to 2 weeks

次要结局

  • Change in Headache Severity(Baseline,1 week, 2 weeks, 4 weeks)
  • Change in Moderate or Severe Headache Days(Baseline, 1 week, 2 weeks, 4 weeks)
  • Change in Acute Medication Use(Baseline, 1 week, 2 weeks, 4 weeks)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carrie (Beth) E. Robertson, MD

Principal Investigator

Mayo Clinic

研究点 (1)

Loading locations...

相似试验