Sphenopalatine Blockade Versus Clinical Treatment
- Conditions
- Headache, Post-Dural Puncture
- Interventions
- Drug: DypironeProcedure: Sphenopalatine blockDietary Supplement: Espresso coffee
- Registration Number
- NCT04148846
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 45
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clinical treatment - old protocol Dypirone In group I, patients will receive clinical treatment according to the institution's old protocol for post dural puncture headache. Clinical treatment - old protocol Ketoprofen In group I, patients will receive clinical treatment according to the institution's old protocol for post dural puncture headache. Clinical treatment - new protocol Dypirone In group II, patients will receive clinical treatment, according to the new protocol of the institution. Clinical treatment - new protocol Ketoprofen In group II, patients will receive clinical treatment, according to the new protocol of the institution. Clinical treatment - new protocol Gabapentin In group II, patients will receive clinical treatment, according to the new protocol of the institution. Clinical treatment - new protocol Dexamethasone In group II, patients will receive clinical treatment, according to the new protocol of the institution. Clinical treatment - new protocol Theophylline In group II, patients will receive clinical treatment, according to the new protocol of the institution. Clinical treatment - new protocol Espresso coffee In group II, patients will receive clinical treatment, according to the new protocol of the institution. Sphenopalatine block Dypirone In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block. Sphenopalatine block Sphenopalatine block In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block. Sphenopalatine block Ketoprofen In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block. Sphenopalatine block Gabapentin In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block. Sphenopalatine block Dexamethasone In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block. Sphenopalatine block Theophylline In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block. Sphenopalatine block Espresso coffee In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block.
- Primary Outcome Measures
Name Time Method Pain scores 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.
- Secondary Outcome Measures
Name Time Method Satisfaction with treatment 2 days Satisfaction with pain management will be assessed using a numerical scale from 0 to 10, with 0 being unsatisfied and 10 being complete satisfaction. Will be reevaluated after 12, 24 and 48 hours.
Basic newborn care 2 days At each moment of evaluation, patients will be asked about any difficulty in breastfeeding or performing basic newborn care.
Blood patch incidence 2 days The incidence of blood patch in each group will be quantified if necessary.
Length of hospital stay 2 days Evaluate how long hospital stay of each patient.
Trial Locations
- Locations (1)
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
🇧🇷São Paulo, Brazil