NCT03512977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

April 12, 2018

Last Update Submit

June 20, 2018

Conditions

Keywords

spinal anesthesiasphenopalatine ganglion blockpostspinal headache

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale Score

    VAS score will be asked to the patients. Visual analog scale (VAS) from 0 to 10. 0(= no anxiety), 10(= highest level of anxiety)

    24 th hour after intervention

Study Arms (2)

Sphenopalatine Ganglion Block Group

EXPERIMENTAL

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

Procedure: sphenopalatine ganglion blockDrug: conservative treatment

Standard Treatment Group

ACTIVE COMPARATOR

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

Drug: conservative treatment

Interventions

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.

Sphenopalatine Ganglion Block Group

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

Sphenopalatine Ganglion Block GroupStandard Treatment Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derince Research and Training Hospital

Kocaeli, 41900, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache DisordersCentral Nervous System DiseasesPost-Dural Puncture Headache

Interventions

Sphenopalatine Ganglion BlockConservative Treatment

Condition Hierarchy (Ancestors)

Brain DiseasesNervous System DiseasesHeadache Disorders, Secondary

Intervention Hierarchy (Ancestors)

Autonomic Nerve BlockNerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, OperativeTherapeutics

Study Officials

  • mehmet yilmaz

    Sağlık Bilimleri Üniversitesi Kocaeli Derince Eğitim ve Araştırma Hastanesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

April 12, 2018

First Posted

May 1, 2018

Study Start

December 1, 2017

Primary Completion

June 15, 2018

Study Completion

June 15, 2018

Last Updated

June 21, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations