Sphenopalatine Blockade Versus Clinical Treatment
Primary Purpose
Headache, Post-Dural Puncture
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dypirone
Sphenopalatine block
Ketoprofen
Gabapentin
Dexamethasone
Theophylline
Espresso coffee
Sponsored by
About this trial
This is an interventional treatment trial for Headache, Post-Dural Puncture
Eligibility Criteria
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.
Sites / Locations
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Clinical treatment - old protocol
Clinical treatment - new protocol
Sphenopalatine block
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Basic newborn care
At each moment of evaluation, patients will be asked about any difficulty in breastfeeding or performing basic newborn care.
Blood patch incidence
The incidence of blood patch in each group will be quantified if necessary.
Length of hospital stay
Evaluate how long hospital stay of each patient.
Full Information
NCT ID
NCT04148846
First Posted
October 30, 2019
Last Updated
October 30, 2019
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04148846
Brief Title
Sphenopalatine Blockade Versus Clinical Treatment
Official Title
COMPARATION BETWEEN SPHENOPALATINE BLOCK AND MULTIMODAL CLINICAL TREATMENT IN TREATMENT OF HEADACHE AFTER DURAL PUNCTION IN PREGNANT WOMEN.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
September 25, 2020 (Anticipated)
Study Completion Date
February 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Post-Dural Puncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clinical treatment - old protocol
Arm Type
Active Comparator
Arm Description
In group I, patients will receive clinical treatment according to the institution's old protocol for post dural puncture headache.
Arm Title
Clinical treatment - new protocol
Arm Type
Active Comparator
Arm Description
In group II, patients will receive clinical treatment, according to the new protocol of the institution.
Arm Title
Sphenopalatine block
Arm Type
Experimental
Arm Description
In group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block.
Intervention Type
Drug
Intervention Name(s)
Dypirone
Intervention Description
Dipyrone 2g, 6 / 6h for 7 days, orally or intravenous
Intervention Type
Procedure
Intervention Name(s)
Sphenopalatine block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketoprofen
Intervention Description
Ketoprofen 100 mg, 12 / 12h for 5 days, orally or intravenous
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin 300 mg 8 / 8h for 7 days orally
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 4mg 8 / 8h for 48h orally
Intervention Type
Drug
Intervention Name(s)
Theophylline
Intervention Description
Theophylline 200mg, 12 / 12h, for 5 days, orally
Intervention Type
Dietary Supplement
Intervention Name(s)
Espresso coffee
Intervention Description
Espresso coffee 20ml, 5x / day, for 7 days
Primary Outcome Measure Information:
Title
Pain scores
Description
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.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Satisfaction with treatment
Description
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.
Time Frame
2 days
Title
Basic newborn care
Description
At each moment of evaluation, patients will be asked about any difficulty in breastfeeding or performing basic newborn care.
Time Frame
2 days
Title
Blood patch incidence
Description
The incidence of blood patch in each group will be quantified if necessary.
Time Frame
2 days
Title
Length of hospital stay
Description
Evaluate how long hospital stay of each patient.
Time Frame
2 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hermann S Fernandes, PhD
Phone
+55 84 988966348
Email
hermann.fernandes@hc.fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Ballarin, MD
Phone
+55 11 971274048
Email
mballarinalbino@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hermann S Fernandes, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hermann S Fernandes, PhD
Phone
+55 84 988966348
Email
hermann.fernandes@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Marina Ballarin, MD
Phone
+55 11 971274049
Email
Marina Ballarin Albino <mballarinalbino@gmail.com>
First Name & Middle Initial & Last Name & Degree
Marina Ballarin, MD
First Name & Middle Initial & Last Name & Degree
Nicole Castro, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Sphenopalatine Blockade Versus Clinical Treatment
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