Sphenopalatine Blockade Versus Clinical Treatment

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Headache, Post-Dural Puncture

Treatments: Drug: Dexamethasone; Drug: Ketoprofen; Drug: Dypirone; Dietary Supplement: Espresso coffee; Drug: Theophylline; Drug: Gabapentin; Procedure: Sphenopalatine block

Study type: Interventional

Funder types: Other

Identifiers

NCT04148846

06860018.0.0000.0068

Details and patient eligibility

About

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.

Full 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).

Enrollment: 45 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Clinical treatment - old protocol

Active Comparator group

Description:

In group I, patients will receive clinical treatment according to the institution's old protocol for post dural puncture headache.

Treatment:

Drug: Ketoprofen

Drug: Dypirone

Clinical treatment - new protocol

Active Comparator group

Description:

In group II, patients will receive clinical treatment, according to the new protocol of the institution.

Treatment:

Drug: Ketoprofen

Drug: Dypirone

Dietary Supplement: Espresso coffee

Drug: Theophylline

Drug: Gabapentin

Drug: Dexamethasone

Sphenopalatine block

Experimental group

Description:

In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block.

Treatment:

Drug: Ketoprofen

Drug: Dypirone

Dietary Supplement: Espresso coffee

Drug: Theophylline

Drug: Gabapentin

Drug: Dexamethasone

Procedure: Sphenopalatine block