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临床试验/CTRI/2024/06/068282
CTRI/2024/06/068282尚未招募3 期

A study to compare efficacy of oral methylprednisolone and sphenopalatine block in postdural puncture headache

Dr Mohd Rasheed1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Relief with symptoms by Visual Analogue scale

研究概览

简要总结

Need for the study :

The international headache society (IHS) defines PDPH(post dural puncture headache) as a headache occurring within 5 days of a lumbar puncture caused by CSF leakage through the dural puncture. PDPH is one of most common complications in spinal anesthesia after obstetrics and gynaecological surgeries.  The PDPH clinically is very characteristic, with frontal and/or occipital headache, exacerbated with orthostatism, and relieved in decubitus, which appears 6 to 72 hours after the procedure (90% starts up to 3 days after the procedure and 66% in the first 48 hours). Other symptoms may also be associated, such as nausea, dizziness, stiff neck, visual and/or auditory changes. Without any treatment, PDPH can persist for about two weeks (it is estimated that 72% of cases will resolve spontaneously after 7 days). Incidence of PDPH ranges from 4-18% in obstetrics and gynaecology surgical cases. It is often exhausting, hindering the mother from taking care of the newborn baby in obstetrics cases. This causes raised healthcare costs, extended stay in the hospital, and frequent visits to the emergency department. PDPH can be managed with conservative treatment like bed rest, good hydration, analgesics like paracetamol, methylxanthines like caffeine and gamma aminobutyric acid like pregabalin or gabapentin. Some researchers have also used corticosteroids for the management of PDPH. PDPH resistant to all therapy can be managed with epidural blood patch. Corticosteroids have been widely used for as multimodal analgesia protocols for managing postoperative pain. Oral methylprednisolone has been used for low pressure headache associated with syndrome of spontaneous intracranial hypotension (SSIH). Hence it has been used in the treatment of PDPH. Sphenopalatine ganglion block (SPGB), a non-invasive intervention with minimal adverse effects and high efficacy, had been tried as a treatment modality of PDPH. SPGB efficacy has been proved in the management of migraine and facial pain. There are a number of case reports and case series reporting the success of SPGB for the management of spinal headache in obstetric patients. But due to its minimal invasive nature along dyscomfort to patient while application and easy acceptibility of oral medication for patients, we decided to study and compare the efficacy of oral methylprednisolone and sphenopalatine ganglion block in postdural puncture headache after spinal anesthesia in obstetrics and gynaecology surgical cases.

Aim and objectives:

To observe and compare the efficacy of oral methylprednisolone and sphenopalatine ganglion block in postdural puncture headache after spinal anesthesia in obstetrics and gynaecology surgical cases

Methodology:

Patients who developed postdural puncture headache(PDPH) after obstetrics and gynaecology surgeries will be selected for study in command hospital Air Force Bangalore and randomnly assigned to two groups. Group A (n=15) cases will be managed with oral methylprednisolone 8 mg once a daily for 3 days along with other conservative treatment like bed rest, adequate hydration therapy. Group B (n=15) will be managed with sphenopalatine ganglion block using bupivacaine 2 % intranasal route for spinal headache along with other conservative treatment like bed rest and adequate hydration therapy. Both groups will be assessed with visual analogue scale(VAS) graded 0-10 for pain severity post treatment at just before starting of treatment (0 hr) then followed by at 12 hr, 24 hr, 48 hr, and 72 hr. Zero was considered as no pain and 10 as severe pain; 0-1 (no headache),2-4 (mild headache), 5-7 (moderate headache) and 8-10 (severe headache). If headache was persist even after 3 days of treatment the autologous epidural blood patch (EBP) will be given to patients. Both groups will be compared and assessed for efficacy of methylprednisolone compared to sphenopalatine block in treating PDPH.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
19.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Patients who developed postdural puncture headache after spinal anesthesia in obstetrics and gynaecology surgical procedure.

排除标准

  • Patients with h/o migraine or other types of headache Neurological disorders Cerebrovascular accidents Cerebrovascular infection Conditions where methylprednisolone is contraindicated.

结局指标

主要结局

Relief with symptoms by Visual Analogue scale

时间窗: on day 0 followed by day 1, day 2, day 3,day 4 and day 5

次要结局

  • 1. Number of days with headache according to visual analogue scale(2. Toal Hospitalization days due to headache)

研究者

发起方
Dr Mohd Rasheed
申办方类型
Other [guide]
责任方
Principal Investigator
主要研究者

Tania Singh

Command Hospital Air Force Bangalore

研究点 (1)

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