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临床试验/NCT04657952
NCT04657952Unknown4 期

Sphenopalatine Ganglion Block With Adrenaline Additive for Post-Dural Puncture Headache in Orthopedic Patients: A Randomized Controlled Study

Tanta University0 个研究点目标入组 60 人开始时间: 2020年12月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
主要终点
Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours

研究概览

简要总结

The aim of this study is to assess the efficacy, onset and duration of analgesia of sphenopalatine ganglion bock (SPGB) using lidocaine 4% with adrenaline as a treatment of postoperative Post dural puncture headache (PDPH) of orthopedic patients after lower limbs surgeries.

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to the orthopedic department
  • Complaining of criteria of severe post-dural puncture headache within 7 days following subarachnoid block used for lower limbs surgeries.
  • American Society of Anesthesiologists (ASA) physical status I and II.

排除标准

  • Patient refusal or uncooperative.
  • Patients with uncontrollable hypertension.
  • Patient with known coagulopathy.
  • Patient with nasal septal deviation, polyp, history of nasal bleeding.
  • Patient with allergy to local anesthetics
  • American Society of Anesthesiologists physical status>2.

研究组 & 干预措施

Standard medical Treatment (paracetamol)

Active Comparator

Patients will receive paracetamol 1 gm every 6 hours daily intravenously for a day.

干预措施: Medical Treatment (Drug)

Sphenopalatine block

Experimental

Patients will receive sphenopalatine block

干预措施: Sphenopalatine Ganglion Block (Procedure)

结局指标

主要结局

Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours

时间窗: 48 hours

Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours. VAS ranges from 0 to 10; 10 with worse outcome

次要结局

  • Duration of analgesia(48 hours)
  • Adverse events(48 hours)
  • Onset of analgesia(48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hussen Gamal Almawardy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

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