Sphenopalatine Blockade Versus Clinical Treatment

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

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.

Study Overview

• Status: Unknown
• Conditions: Headache, Post-Dural Puncture
• Intervention / Treatment: Drug: Dypirone; Drug: Ketoprofen; Drug: Gabapentin; Drug: Dexamethasone; Drug: Theophylline; Dietary supplement: Espresso coffee; Procedure: Sphenopalatine block

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hermann S Fernandes, PhD; Phone Number: +55 84 988966348; Email: hermann.fernandes@hc.fm.usp.br
• Study Contact Backup: Name: Marina Ballarin, MD; Phone Number: +55 11 971274048; Email: mballarinalbino@gmail.com

Study Locations

• Brazil
  • São Paulo, Brazil, 05403000
    • Recruiting
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
    • Contact: Hermann S Fernandes, PhD; Phone Number: +55 84 988966348; Email: hermann.fernandes@hc.fm.usp.br
    • Contact: Marina Ballarin, MD; Phone Number: +55 11 971274049; Email: Marina Ballarin Albino <mballarinalbino@gmail.com>
    • Principal Investigator: Marina Ballarin, MD
    • Sub-Investigator: Nicole Castro, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinical treatment - old protocol; In group I, patients will receive clinical treatment according to the institution's old protocol for post dural puncture headache.	Drug: Dypirone; Dipyrone 2g, 6 / 6h for 7 days, orally or intravenous; Drug: Ketoprofen; Ketoprofen 100 mg, 12 / 12h for 5 days, orally or intravenous
Active Comparator: Clinical treatment - new protocol; In group II, patients will receive clinical treatment, according to the new protocol of the institution.	Drug: Dypirone; Dipyrone 2g, 6 / 6h for 7 days, orally or intravenous; 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
Experimental: Sphenopalatine block; In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block.	Drug: Dypirone; Dipyrone 2g, 6 / 6h for 7 days, orally or intravenous; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Study Chair: Hermann S Fernandes, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Anticipated): September 25, 2020
• Study Completion (Anticipated): February 15, 2021

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Purinergic Antagonists; Purinergic Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Dexamethasone; Gabapentin; Theophylline; Ketoprofen
• Other Study ID Numbers: 06860018.0.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No