Sphenopalatine Blockade Versus Clinical Treatment

Study Overview
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Brief Summary
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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
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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).

Official Title
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COMPARATION BETWEEN SPHENOPALATINE BLOCK AND MULTIMODAL CLINICAL TREATMENT IN TREATMENT OF HEADACHE AFTER DURAL PUNCTION IN PREGNANT WOMEN.

Conditions
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Headache, Post-Dural Puncture

Intervention / Treatment
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* Drug: Dypirone
* Procedure: Sphenopalatine block
* Drug: Ketoprofen
* Drug: Gabapentin
* Drug: Dexamethasone
* Drug: Theophylline
* Dietary Supplement: Espresso coffee


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 Clinical Hospital (ICHC-FMUSP). Postpartum women undergoing neuraxial block for cesarean section, vaginal delivery or uterine curettage, and who later present with cerebrospinal fluid hypotension, will be studied after evaluation and diagnosis by anesthesiologist. The research will be submitted for evaluation by the Research Ethics Committees, according to resolution 196/96. Patients will be approached as to the eligibility of their participation in the study, and after the necessary clarifications, will authorize or not the proposed interventions and data collection, by signing the Informed Consent Form.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinical treatment - old protocol<br>In group I, patients will receive clinical treatment according to the institution's old protocol for post dural puncture headache. | Drug: Dypirone<br>* Dipyrone 2g, 6 / 6h for 7 days, orally or intravenous<br>Drug: Ketoprofen<br>* Ketoprofen 100 mg, 12 / 12h for 5 days, orally or intravenous<br>|
| Active Comparator: Clinical treatment - new protocol<br>In group II, patients will receive clinical treatment, according to the new protocol of the institution. | Drug: Dypirone<br>* Dipyrone 2g, 6 / 6h for 7 days, orally or intravenous<br>Drug: Ketoprofen<br>* Ketoprofen 100 mg, 12 / 12h for 5 days, orally or intravenous<br>Drug: Gabapentin<br>* Gabapentin 300 mg 8 / 8h for 7 days orally<br>Drug: Dexamethasone<br>* Dexamethasone 4mg 8 / 8h for 48h orally<br>Drug: Theophylline<br>* Theophylline 200mg, 12 / 12h, for 5 days, orally<br>Dietary Supplement: Espresso coffee<br>* Espresso coffee 20ml, 5x / day, for 7 days<br>|
| Experimental: Sphenopalatine block<br>In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block. | Drug: Dypirone<br>* Dipyrone 2g, 6 / 6h for 7 days, orally or intravenous<br>Procedure: Sphenopalatine block<br>* The sphenopalatine block will be performed with the patient in the supine position, with neck extended. Following topical anesthesia of the nasal vestibules with one application of 10% lidocaine spray and one application of 2% lidocaine gel in each nostril, two long cotton swab applicators embedded in 2% lidocaine jelly, one in each nostril, will be introduced. They will be advanced at a 45-degree angle to the floor of the nose until resistance is encountered, indicating that the swab is in the posterior nasopharyngeal wall, superior to the middle nasal concha. It will be held in this position for 5 minutes and then removed. Thereafter, a 14 gauge, non-cutting, teflon blunt catheter will be introduced into each nostril at a 45 ° angle to the hard palate until it touches the posterior wall of the nasopharynx. For it will be applied 2ml of 0.375% Ropivacaine, on each side, slowly.<br>Drug: Ketoprofen<br>* Ketoprofen 100 mg, 12 / 12h for 5 days, orally or intravenous<br>Drug: Gabapentin<br>* Gabapentin 300 mg 8 / 8h for 7 days orally<br>Drug: Dexamethasone<br>* Dexamethasone 4mg 8 / 8h for 48h orally<br>Drug: Theophylline<br>* Theophylline 200mg, 12 / 12h, for 5 days, orally<br>Dietary Supplement: Espresso coffee<br>* Espresso coffee 20ml, 5x / day, for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | 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. | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with treatment | 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. | 2 days | 
| Basic newborn care | At each moment of evaluation, patients will be asked about any difficulty in breastfeeding or performing basic newborn care. | 2 days | 
| Blood patch incidence | The incidence of blood patch in each group will be quantified if necessary. | 2 days | 
| Length of hospital stay | Evaluate how long hospital stay of each patient. | 2 days |