Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000041156p
Ethics application status
Submitted, not yet approved
Date submitted
17/12/2018
Date registered
14/01/2019
Date last updated
14/01/2019
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Characteristics of sphenopalatine blocks in the treatment of postdural puncture headaches.
Scientific title
Characteristics of sphenopalatine blocks in the treatment of postdural puncture headaches.
Secondary ID [1] 296920 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postdural Puncture Headache 310636 0
Neurological 310872 0
Condition category
Condition code
Anaesthesiology 309355 309355 0 0
Pain management
Neurological 309545 309545 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
7
Target follow-up type
Days
Description of intervention(s) / exposure
Acquisiton of additional data from patients who have elected to undergo a sphenopalatine block for the treatment of their postdural puncture headache. This involves additional assessments at 30mins, 1 hour and hourly until the return of gag reflex. It is anticipated that this will involve 3 assessments for most patients (30min, 1hr and 2hr)immeadiately post block performance. Each assessment lasts <5mins. Patients will be followed up the following day and the day after (day 1 and 2)-which will routinely occur as part of the management of patients suffering from a PDPH and at one week(phone review)-again which would happen to patients suffering from a PDPH. Again these assessments will last <5mins.
Intervention code [1] 313066 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308311 0
Pain from headache score post block performance (scored x/10)
Timepoint [1] 308311 0
Primary outcome will be pain score from headache (scored x/10) one hour post block performance.
Secondary outcome [1] 354594 0
Presence/absence of gag reflex post block performance-assessed by clinical examination by eliciting a gag reflex on both the right and left side. ie clinical stimulation of gag by touching the posterior wall of the oropharynx with either a sterile swab or tongue depressor.
Timepoint [1] 354594 0
Alteration of gag reflex at 1 hour post block performance
Secondary outcome [2] 355151 0
Time to return of normal gag reflex-assessed as above. ie clinical stimulation of gag by touching the posterior wall of the oropharynx with either a sterile swab or tongue depressor.
Timepoint [2] 355151 0
Hourly assessment post block performance. Anticipated that all gag reflexes will be normal at 2 hours.
Secondary outcome [3] 355152 0
Requirement for epidural blood patch within 7 days
Timepoint [3] 355152 0
The performance of an epidural blood patch as assessed by phone follow up at 7 days post block performance.
Secondary outcome [4] 365479 0
Change in systolic blood pressure of >10% at 1 hour. Pre-block as assessed by the last blood pressure taken as part of routine ward care by ward nursing staff. Systolic blood pressure to be measured by ward staff 1 hour post block performance.
Timepoint [4] 365479 0
1 hour post block performance.
Secondary outcome [5] 365481 0
Patient requirement of opiates to treat the headache post block. Data collected from medication record.
Timepoint [5] 365481 0
Time interval between performance of the sphenopalatine block and day 1 post block review.

Eligibility
Key inclusion criteria
Consenting adult patients
Headache that is postural in nature
Recent spinal or epidural anaesthetic
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal to consent
Headache that is not clinically consistent with a postdural puncture headache
Unable to consent without the aid of a third party

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Observational data will be acquired. Simple analysis only.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/01/2019
Actual
Date of last participant enrolment
Anticipated
28/01/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12613 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [2] 12614 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 25032 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 301334 0
Hospital
Name [1] 301334 0
Mater health Services
Country [1] 301334 0
Australia
Primary sponsor type
Hospital
Name
Dept Anaesthesia, Mater Health Services
Address
Dept Anaesthesia, Mater Health Services
Raymond Terrace, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 301000 0
None
Name [1] 301000 0
Address [1] 301000 0
Country [1] 301000 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302198 0
Mater Misericordiae Ltd Human Research Ethics Committee EC00332
Ethics committee address [1] 302198 0
Ethics committee country [1] 302198 0
Australia
Date submitted for ethics approval [1] 302198 0
03/12/2018
Approval date [1] 302198 0
Ethics approval number [1] 302198 0
pending

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89034 0
Dr John Riordan
Address 89034 0
Dept. Anaesthesia, Raymond Terrace, South Brisbane QLD 4101
Country 89034 0
Australia
Phone 89034 0
+61 0467564641
Fax 89034 0
Email 89034 0
[email protected]
Contact person for public queries
Name 89035 0
John Riordan
Address 89035 0
Dept. Anaesthesia, Raymond Terrace, South Brisbane QLD 4101
Country 89035 0
Australia
Phone 89035 0
+61 0467564641
Fax 89035 0
Email 89035 0
[email protected]
Contact person for scientific queries
Name 89036 0
John Riordan
Address 89036 0
Dept. Anaesthesia, Raymond Terrace, South Brisbane QLD 4101
Country 89036 0
Australia
Phone 89036 0
+61 0467564641
Fax 89036 0
Email 89036 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.