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临床试验/CTRI/2025/10/095570
CTRI/2025/10/095570尚未招募2/3 期

Comparison of Transnasal Versus Ultrasound Guided Percutaneous Approach for Sphenopalatine Ganglion Block in Patients with Chronic Migraine

Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年10月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
88
试验地点
1
主要终点
Number of Headaches post procedure monthly upto 3 months

研究概览

简要总结

The study involves two groups of patients undergoing sphenopalatine ganglion (SPG) block after obtaining informed consent.

In Group 1, patients receive a transnasal SPG block in the supine position with mild neck extension. A long-tipped cotton applicator soaked with 0.5 ml of 2% lidocaine is advanced transnasally to the posterolateral surface of the nasopharynx at the level of the middle turbinate.

In Group 2, patients undergo an ultrasound-guided percutaneous SPG block under sterile conditions without sedation, using only local anesthesia. A high-frequency linear ultrasound probe (10–15 MHz) is placed transversely above the zygomatic arch and anterior to the temporal fossa to identify key landmarks, including the maxilla, zygomatic arch, temporal fossa, and the pterygopalatine fossa. Under real-time ultrasound guidance, a needle is advanced carefully, avoiding vascular structures, and hydrodissection may be performed to confirm precise tissue plane entry. Once non-vascular placement is confirmed, 1.5–3 ml of either 0.25–0.5% bupivacaine or 2%lidocaine with or without steroid, is injected to achieve blockade. All patients are monitored and followed up at one, two, and three months after the procedure.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Diagnosis of Chronic migraine according to ICHD-3 Criteria
  • Patient without any secondary headaches.

排除标准

  • Patients who had a history of trauma or surgery involving the head and neck area with any etiology.
  • Patients who had any anatomical deformation that disrupted the head and neck contour
  • Patients with a history of severe psychiatric illness.
  • Patients with possible tooth and palate pathologies which are detected with detailed evaluation by the Dentist and Ent specialists.
  • Presence of Secondary Headache Aetiology (tumour , bleeding , stroke).
  • History of any Malignancy.

结局指标

主要结局

Number of Headaches post procedure monthly upto 3 months

时间窗: 1st month 2nd month 3rd month

次要结局

  • Severity of pain by NRS in most severe headache in 1 month post procedure evaluated upto 3 months.(1st month 2nd month & 3rd month)
  • Impact of headache using HIT6 score at pre procedure & post procedure monthly upto 3 months(1st month 2nd month 3rd month)
  • Impact of headache using MIDAS score at pre procedure level & at 3rd month post procedure.(1st month 3rd month)

研究者

发起方
Atal Bihari Vajpayee Institute of Medical Sciences and Dr Ram Manohar Lohia Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Kartik Guleria

ABVIMS and Dr RML Hospital New Delhi

研究点 (1)

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