Sphenopalatine Blockade Versus Clinical Treatment

NCT04148846 | Unknown

• 1 other identifier: 06860018.0.0000.0068
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache, Post-Dural Puncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Satisfaction with treatment

  2 days

• Basic newborn care

  2 days

• Blood patch incidence

  2 days

• Length of hospital stay

  2 days

Study Arms (3)

Clinical treatment - old protocol

ACTIVE COMPARATOR

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

Drug: Dypirone; Drug: Ketoprofen

Clinical treatment - new protocol

ACTIVE COMPARATOR

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

Drug: Dypirone; Drug: Ketoprofen; Drug: Gabapentin; Drug: Dexamethasone; Drug: Theophylline; Dietary Supplement: Espresso coffee

Sphenopalatine block

EXPERIMENTAL

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

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

Interventions

Dypirone DRUG

Dipyrone 2g, 6 / 6h for 7 days, orally or intravenous

Clinical treatment - new protocol; Clinical treatment - old protocol; Sphenopalatine block

Sphenopalatine block PROCEDURE

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.

Sphenopalatine block

Ketoprofen DRUG

Ketoprofen 100 mg, 12 / 12h for 5 days, orally or intravenous

Clinical treatment - new protocol; Clinical treatment - old protocol; Sphenopalatine block

Gabapentin DRUG

Gabapentin 300 mg 8 / 8h for 7 days orally

Clinical treatment - new protocol; Sphenopalatine block

Dexamethasone DRUG

Dexamethasone 4mg 8 / 8h for 48h orally

Clinical treatment - new protocol; Sphenopalatine block

Theophylline DRUG

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

Clinical treatment - new protocol; Sphenopalatine block

Espresso coffee DIETARY_SUPPLEMENT

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

Clinical treatment - new protocol; Sphenopalatine block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Sphenopalatine Ganglion Block; Ketoprofen; Gabapentin; Dexamethasone; Theophylline

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Cyclohexanecarboxylic Acids; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hermann S Fernandes, PhD

  University of Sao Paulo

  STUDY CHAIR

Central Study Contacts

Hermann S Fernandes, PhD

CONTACT

+55 84 988966348; hermann.fernandes@hc.fm.usp.br

Marina Ballarin, MD

CONTACT

+55 11 971274048; mballarinalbino@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will be randomly divided into three groups according to the reduced distribution of use of the site www.randomization.com to be conducted prior to the commencement of surveys and data collection. Each patient is given an identification number following a search entry order, and this number is already available through prior randomization linked to one of the three intervention groups. The professional who administers as drugs will be external to the research group and may cause non-burdensome form. Researchers who perform the evaluations of the researched variables can obtain the following results for the intervention performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 4, 2019
• Study Start: September 20, 2019
• Primary Completion: September 25, 2020
• Study Completion: February 15, 2021
• Last Updated: November 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)