Sphenopalatine Blockade Versus Clinical Treatment

Headache, Post-Dural Puncture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04148846
• Other study ID #: 06860018.0.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: February 15, 2021

Study information

• Verified date: September 2019
• Source: University of Sao Paulo General Hospital
• Contact: Hermann S Fernandes, PhD
• Phone: +55 84 988966348
• Email: hermann.fernandes[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: February 15, 2021
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Headache, Post-Dural Puncture
• Post-Dural Puncture Headache

Intervention

Drug:
• Dypirone
Dipyrone 2g, 6 / 6h for 7 days, orally or intravenous

Procedure:
• Sphenopalatine block
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.

Drug:
• Ketoprofen
Ketoprofen 100 mg, 12 / 12h for 5 days, orally or intravenous
• Gabapentin
Gabapentin 300 mg 8 / 8h for 7 days orally
• Dexamethasone
Dexamethasone 4mg 8 / 8h for 48h orally
• Theophylline
Theophylline 200mg, 12 / 12h, for 5 days, orally

Dietary Supplement:
• Espresso coffee
Espresso coffee 20ml, 5x / day, for 7 days

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Basic newborn care	At each moment of evaluation, patients will be asked about any difficulty in breastfeeding or performing basic newborn care.	2 days
Secondary	Blood patch incidence	The incidence of blood patch in each group will be quantified if necessary.	2 days
Secondary	Length of hospital stay	Evaluate how long hospital stay of each patient.	2 days