COMPARATION BETWEEN SPHENOPALATINE BLOCK AND MULTIMODAL CLINICAL TREATMENT IN TREATMENT OF HEADACHE AFTER DURAL PUNCTION IN PREGNANT WOMEN.
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pain scores
研究概览
简要总结
Post-dural puncture headache leads to high morbidity and cost to the health system. Pregnant women have a higher incidence than other population groups. There are several treatments for post dural puncture headache mentioned in the literature, not all well established, with a wide heterogeneity of treatment between services. Sphenopalatine block then appears as an alternative treatment, having been described as effective in reports and case series, requiring comparative experimental studies.
详细描述
Post-dural puncture headache leads to high morbidity and cost to the health system. Pregnant women have a higher incidence than other population groups. There are several treatments for post dural puncture headache mentioned in the literature, not all well established, with a wide heterogeneity of treatment between services. Sphenopalatine block then appears as an alternative treatment, having been described as effective in reports and case series, requiring comparative experimental studies.
OBJECTIVES: To evaluate the efficacy of sphenopalatine blockade in combination with multimodal treatment in reducing the incidence of epidural blood patch and pain intensity in patients who develop headache after dural puncture, compared with the clinical treatment in our service.
METHODS: A prospective randomized clinical, analytical study will be conducted at the Obstetric Center of the Central Institute of the University of São Paulo School of Medicine Hospital das Clínicas (ICHC-FMUSP). Women will be included who will undergo neuroaxis block for cesarean section, vaginal delivery or uterine curettage, and who later present headache after dural puncture, after evaluation and diagnosis by anesthesiologist. The patients will be divided into three groups at random. In group I, patients will receive clinical treatment according to the institution's old protocol for post dural puncture headache. In group II, patients will receive clinical treatment, according to the new protocol of the institution. In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block. They will be reevaluated after 12, 24 and 48 hours, and a visual analog scale will be applied to evaluate improvement. The pain will be quantified before and after treatment. Pain intensity will be evaluated by verbal numerical scale (EVN), incidence of need for epidural blood buffer in each group, as well as length of hospital stay (in days).
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
- Single (Participant)
盲法说明
The patients will be randomly divided into three groups according to the reduced distribution of use of the site www.randomization.com to be conducted prior to the commencement of surveys and data collection. Each patient is given an identification number following a search entry order, and this number is already available through prior randomization linked to one of the three intervention groups. The professional who administers as drugs will be external to the research group and may cause non-burdensome form. Researchers who perform the evaluations of the researched variables can obtain the following results for the intervention performed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women who will undergo neuroaxis block for cesarean section, vaginal delivery or uterine curettage, and who later present with cerebrospinal fluid hypotension headache, after evaluation and diagnosis by anesthesiologist.
排除标准
- •patients previously diagnosed with chronic headache; patients with contraindication for neuraxial anesthesia, patients with contraindication for any drugs involved in the study and users of psychotropic intravenous drugs.
研究组 & 干预措施
Clinical treatment - old protocol
In group I, patients will receive clinical treatment according to the institution's old protocol for post dural puncture headache.
干预措施: Dypirone (Drug)
Clinical treatment - old protocol
In group I, patients will receive clinical treatment according to the institution's old protocol for post dural puncture headache.
干预措施: Ketoprofen (Drug)
Clinical treatment - new protocol
In group II, patients will receive clinical treatment, according to the new protocol of the institution.
干预措施: Dypirone (Drug)
Clinical treatment - new protocol
In group II, patients will receive clinical treatment, according to the new protocol of the institution.
干预措施: Ketoprofen (Drug)
Clinical treatment - new protocol
In group II, patients will receive clinical treatment, according to the new protocol of the institution.
干预措施: Gabapentin (Drug)
Clinical treatment - new protocol
In group II, patients will receive clinical treatment, according to the new protocol of the institution.
干预措施: Dexamethasone (Drug)
Clinical treatment - new protocol
In group II, patients will receive clinical treatment, according to the new protocol of the institution.
干预措施: Theophylline (Drug)
Clinical treatment - new protocol
In group II, patients will receive clinical treatment, according to the new protocol of the institution.
干预措施: Espresso coffee (Dietary Supplement)
Sphenopalatine block
In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block.
干预措施: Dypirone (Drug)
Sphenopalatine block
In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block.
干预措施: Sphenopalatine block (Procedure)
Sphenopalatine block
In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block.
干预措施: Ketoprofen (Drug)
Sphenopalatine block
In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block.
干预措施: Gabapentin (Drug)
Sphenopalatine block
In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block.
干预措施: Dexamethasone (Drug)
Sphenopalatine block
In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block.
干预措施: Theophylline (Drug)
Sphenopalatine block
In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block.
干预措施: Espresso coffee (Dietary Supplement)
结局指标
主要结局
Pain scores
时间窗: 2 days
Headache intensity will be assessed using a numerical verbal scale (EVN) from 0 to 10, with 0 being no pain and 10 being the worst possible pain. Patients will quantify pain before and after treatment. Will be reevaluated after 12, 24 and 48 hours.
次要结局
- Satisfaction with treatment(2 days)
- Basic newborn care(2 days)
- Blood patch incidence(2 days)
- Length of hospital stay(2 days)