Sphenopalatine Blockade Versus Clinical Treatment

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04148846

Collaborator

(none)

Enrollment

Location

Arms

16.9

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Headache, Post-Dural Puncture	Drug: Dypirone Procedure: Sphenopalatine block Drug: Ketoprofen Drug: Gabapentin Drug: Dexamethasone Drug: Theophylline Dietary Supplement: Espresso coffee	N/A

Detailed Description

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

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 20, 2019

Anticipated Primary Completion Date :

Sep 25, 2020

Anticipated Study Completion Date :

Feb 15, 2021

Arms and Interventions

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 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. 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

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

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.

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

Outcome Measures

Primary Outcome Measures

Pain scores [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.

Secondary Outcome Measures

Satisfaction with treatment [2 days]
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 [2 days]
At each moment of evaluation, patients will be asked about any difficulty in breastfeeding or performing basic newborn care.
Blood patch incidence [2 days]
The incidence of blood patch in each group will be quantified if necessary.
Length of hospital stay [2 days]
Evaluate how long hospital stay of each patient.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.