Is Sphenopalatine Ganglion Block Treatment Effective on Postspinal Headaches

NCT ID: NCT03512977

Last Updated: 2018-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-06-15

Brief Summary

This study evaluates effect of sphenopalatine ganglion block in post dural puncture headache. Half of participants will receive standard supportive treatment and other half of patients will be performed sphenopalatine ganglion block.

Detailed Description

Spinal anesthesia is known subarachnoid block also commonly used regional anesthesia technic. Spinal anesthesia is frequently performed in obstetric patients undergoing cesarian section, which has several advantages including less deep vein thrombosis incidence, low opioid requirement, early mobilization and early lactation also has some complications too. Postdural headache is one of the most known complications of spinal anesthesia.

The etiology of the postspinal headache remains unclear. Severeness of the symptoms and amount of the cerebrospinal fluid leakage have been found positive correlating. The cerebrospinal fluid supports brain with it's mass effect. When a leakage of the fluid occurs, support of the brain decreases and pain sensitive structures of the brain gets more sensitive. In this condition 5 th 9th and 10 th cranial nerves, falks cerebelli, tentorium and blood vessels are affected most. Decreased cerebrospinal fluid volume causes decreased brain volume and compensatory mechanisms lead to cerebral venous dilatation. Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline. Epidural blood patch is the gold standard for the treatment . However epidural blood patch is an invasive technic and has some complications such as dural puncture, infection and neurologic trauma.

Sphenopalatine ganglion is one of the four parasympathetic thin ganglion in skull. Parasympathetic fibers innervates cerebral and meningeal blood vessels which cause vasodilatation and stimulate nociceptor activation on meninges. Consequently headache is related with sensory cortex.

Transnasal SPG block is performed successfully in chronic pain syndromes including migraine, cluster headaches and atypic face pain. Likewise the SPG block is performed in acute treatment of postspinal headache. However gold standard of the treatment is epidural blood patching which is interventional and has many risks. Several studies enrolled limited participants offer SPG block primarily in the literature.

Conditions

Headache Disorders; Central Nervous System Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sphenopalatine Ganglion Block Group

patients will be performed transnasal sphenopalatine block and conservative treatment ( iv hydration, analgesic agents, caffeine or theophylline)

Group Type: EXPERIMENTAL

sphenopalatine ganglion block

Intervention Type: PROCEDURE

the intervention will be performed on sitting position. Lidocaine 2% viscous (0.5ml) will be apply on cotton swab sticks and one will be gently inserted into nostril, along the floor of the nose. Stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab stick will be left undisturbed for 20 minutes.

conservative treatment

Intervention Type: DRUG

Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline

Standard Treatment Group

patients will receive standard supportive treatment ( Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline)

Group Type: ACTIVE_COMPARATOR

conservative treatment

Intervention Type: DRUG

Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline

Interventions

sphenopalatine ganglion block

the intervention will be performed on sitting position. Lidocaine 2% viscous (0.5ml) will be apply on cotton swab sticks and one will be gently inserted into nostril, along the floor of the nose. Stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab stick will be left undisturbed for 20 minutes.

Intervention Type: PROCEDURE

conservative treatment

Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who was diagnosed for postdural puncture headache after cesarian section
• Patients who is fluent speaking and writing in turkish

Exclusion Criteria

• Refusal to participate in the study
• Patients who was known lidocaine sensitivity
• Patients with severe nasal septum deviation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Derince Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ayse Zeynep Turan

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mehmet yilmaz

Role: STUDY_DIRECTOR

Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi

Locations

Derince Research and Training Hospital

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

DerinceTRH-03

Identifier Type: -

Identifier Source: org_study_id