Sphenopalatine Blockade Versus Clinical Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-20

Study Completion Date

2021-02-15

Brief Summary

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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.

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Detailed Description

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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

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Headache, Post-Dural Puncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Clinical treatment - old protocol

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

Group Type ACTIVE_COMPARATOR

Dypirone

Intervention Type DRUG

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

Ketoprofen

Intervention Type DRUG

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

Clinical treatment - new protocol

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

Group Type ACTIVE_COMPARATOR

Dypirone

Intervention Type DRUG

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

Ketoprofen

Intervention Type DRUG

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

Gabapentin

Intervention Type DRUG

Gabapentin 300 mg 8 / 8h for 7 days orally

Dexamethasone

Intervention Type DRUG

Dexamethasone 4mg 8 / 8h for 48h orally

Theophylline

Intervention Type DRUG

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

Espresso coffee

Intervention Type DIETARY_SUPPLEMENT

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

Sphenopalatine block

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

Group Type EXPERIMENTAL

Dypirone

Intervention Type DRUG

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

Sphenopalatine block

Intervention Type 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.

Ketoprofen

Intervention Type DRUG

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

Gabapentin

Intervention Type DRUG

Gabapentin 300 mg 8 / 8h for 7 days orally

Dexamethasone

Intervention Type DRUG

Dexamethasone 4mg 8 / 8h for 48h orally

Theophylline

Intervention Type DRUG

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

Espresso coffee

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Dypirone

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

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Ketoprofen

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

Intervention Type DRUG

Gabapentin

Gabapentin 300 mg 8 / 8h for 7 days orally

Intervention Type DRUG

Dexamethasone

Dexamethasone 4mg 8 / 8h for 48h orally

Intervention Type DRUG

Theophylline

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

Intervention Type DRUG

Espresso coffee

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No