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临床试验/CTRI/2026/01/100399
CTRI/2026/01/100399尚未招募4 期

Hospital based prospective and double blind randomised control trial - Comparision of efficacy of sphenopalatine ganglion block with intra nasal 4% lignocaine v/s intra nasal dexmedetomidine v/s conservative treatment of post dural puncture headache in patients undergoing surgery under spinal anaesthesia

GSVM MEDICAL COLLEGE KANPUR1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年1月17日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
90
试验地点
1

研究概览

简要总结

Post-dural puncture headache (PDPH) is a common and distressing complication following spinal anaesthesia. Conservative management often provides delayed relief and may prolong hospital stay. Sphenopalatine ganglion block (SPGB) using intranasal agents is a minimally invasive technique that has shown promising results in the management of PDPH. This hospital-based, prospective, double-blind randomized controlled trial aims to compare the efficacy of intranasal 4% lignocaine, intranasal dexmedetomidine, and conservative treatment in patients developing PDPH after surgery under spinal anaesthesia. The primary outcome will be the reduction in headache severity, while secondary outcomes will include duration of analgesia, need for rescue analgesics, and incidence of adverse effects. The results of this study may help identify an effective, safe, and non-invasive treatment option for PDPH.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • Patients giving consent .
  • Patients in ASA Grade 1,2,3 Pateints within 5 days of dural puncture Patients returning to OPD with symptoms of PDPH after discharge.

排除标准

  • Patients not giving consent Patients with chronic headache, tension headache, migraine, Cluster headache.
  • Patients with known nasal septal deviation or abnormalities such as polyps, intranasal tumors Patients with a history of any disorders involving the nose such as sinusitis, rhinitis Patients with a history of allergy to study medications (Lignocaine or Dexmedetomidine or paracetamol ) Patients on analgesic or undergoing treatment for headache.
  • Patients with a history of addiction i.e. alcohol abuse or substance abuse.

研究者

发起方
GSVM MEDICAL COLLEGE KANPUR
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Shivangi sachan

Ganesh Shankar vidyarthi memorial medical college

研究点 (1)

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