Sphenopalatine Blockade Versus Clinical Treatment

NCT04148846 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-11-04

No results posted yet for this study

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.

Conditions

  • Headache, Post-Dural Puncture

Interventions

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

DRUG

Gabapentin

Gabapentin 300 mg 8 / 8h for 7 days orally

DRUG

Dexamethasone

Dexamethasone 4mg 8 / 8h for 48h orally

DRUG

Theophylline

Theophylline 200mg, 12 / 12h, for 5 days, orally

DIETARY_SUPPLEMENT

Espresso coffee

Espresso coffee 20ml, 5x / day, for 7 days

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Hermann S Fernandes, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-20
Primary Completion
2020-09-25
Completion
2021-02-15

Countries

  • Brazil

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04148846 on ClinicalTrials.gov