Headache, Post-Dural PunctureNCT04148846
Sphenopalatine Blockade Versus Clinical Treatment
A study testing Dypirone, Sphenopalatine block and Ketoprofen in people with Headache, Post-Dural Puncture, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Headache, Post-Dural Puncture
- What is being tested?
- Dypirone, Sphenopalatine block and Ketoprofen
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Sep 2019to 15 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403000
Hermann S Fernandes, PhD, +55 84 988966348, hermann.fernandes@hc.fm.usp.br
Marina Ballarin, MD, +55 11 971274049, Marina Ballarin Albino <mballarinalbino@gmail.com>
About this study
Official title: 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.
Read the 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).
- Conditions
- Headache, Post-Dural Puncture
- Being tested
- Dypirone, Sphenopalatine block, Ketoprofen, Gabapentin, Dexamethasone
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DypironeDrug
Dipyrone 2g, 6 / 6h for 7 days, orally or intravenous
Sphenopalatine blockProcedure or surgery
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.
KetoprofenDrug
Ketoprofen 100 mg, 12 / 12h for 5 days, orally or intravenous
GabapentinDrug
Gabapentin 300 mg 8 / 8h for 7 days orally
DexamethasoneDrug
Dexamethasone 4mg 8 / 8h for 48h orally
TheophyllineDrug
Theophylline 200mg, 12 / 12h, for 5 days, orally
Espresso coffeeDietary supplement
Espresso coffee 20ml, 5x / day, for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Dypirone; Procedure: Sphenopalatine block; Drug: Ketoprofen; Drug: Gabapentin; Drug: Dexamethasone; Drug: Theophylline; Dietary Supplement: Espresso coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Secondary outcomes (4)
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.
Measured: 2 days
Basic newborn care
At each moment of evaluation, patients will be asked about any difficulty in breastfeeding or performing basic newborn care.
Measured: 2 days
Blood patch incidence
The incidence of blood patch in each group will be quantified if necessary.
Measured: 2 days
Length of hospital stay
Evaluate how long hospital stay of each patient.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start20 Sep 2019
- Primary completion25 Sep 2020 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache, Post-Dural PunctureStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hermann S Fernandes, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148846
- Sponsor's protocol ID
- 06860018.0.0000.0068
- Status last verified
- Sep 2019
- First submitted
- 30 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATION BETWEEN SPHENOPALATINE BLOCK AND MULTIMODAL CLINICAL TREATMENT IN TREATMENT OF HEADACHE AFTER DURAL PUNCTION IN PREGNANT WOMEN.
- ClinicalTrials.gov ID
- NCT04148846
- Acronym / sponsor ID
- 06860018.0.0000.0068
- Conditions
- Headache, Post-Dural Puncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 25 Sep 2020 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clinical treatment - old protocol | Active comparator | Drug: Dypirone, Drug: KetoprofenIn group I, patients will receive clinical treatment according to the institution's old protocol for post dural puncture headache. |
| Clinical treatment - new protocol | Active comparator | Drug: Dypirone, Drug: Ketoprofen, Drug: Gabapentin, Drug: Dexamethasone, Drug: Theophylline, Dietary Supplement: Espresso coffeeIn group II, patients will receive clinical treatment, according to the new protocol of the institution. |
| Sphenopalatine block | Experimental | Drug: Dypirone, Procedure: Sphenopalatine block, Drug: Ketoprofen, Drug: Gabapentin, Drug: Dexamethasone, Drug: Theophylline, Dietary Supplement: Espresso coffeeIn group III patients will receive clinical treatment, according to the new protocol of the institution, associated with sphenopalatine block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DypironeDipyrone 2g, 6 / 6h for 7 days, orally or intravenous | Drug | Clinical treatment - new protocol, Clinical treatment - old protocol, Sphenopalatine block |
| Sphenopalatine blockThe 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. | Procedure or surgery | Sphenopalatine block |
| KetoprofenKetoprofen 100 mg, 12 / 12h for 5 days, orally or intravenous | Drug | Clinical treatment - new protocol, Clinical treatment - old protocol, Sphenopalatine block |
| GabapentinGabapentin 300 mg 8 / 8h for 7 days orally | Drug | Clinical treatment - new protocol, Sphenopalatine block |
| DexamethasoneDexamethasone 4mg 8 / 8h for 48h orally | Drug | Clinical treatment - new protocol, Sphenopalatine block |
| TheophyllineTheophylline 200mg, 12 / 12h, for 5 days, orally | Drug | Clinical treatment - new protocol, Sphenopalatine block |
| Espresso coffeeEspresso coffee 20ml, 5x / day, for 7 days | Dietary supplement | Clinical treatment - new protocol, Sphenopalatine block |
Primary outcome
Pain scores
Time frame: 2 days
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.
4 secondary outcomes
Satisfaction with treatment
Time frame: 2 days
Basic newborn care
Time frame: 2 days
Blood patch incidence
Time frame: 2 days
Length of hospital stay
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hermann S Fernandes, PhD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dypirone, Sphenopalatine block and Ketoprofen in people with Headache, Post-Dural Puncture, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hermann S Fernandes, PhD (+55 84 988966348, hermann.fernandes@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.