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Trial registered on ANZCTR


Registration number
ACTRN12619000255189
Ethics application status
Approved
Date submitted
6/02/2019
Date registered
20/02/2019
Date last updated
27/06/2019
Date data sharing statement initially provided
20/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Post-dural puncture headache following lumbar puncture with/without intrathecal chemotherapy, how long should patients remain recumbent? A pilot randomised controlled trial (The PLANE Study)
Scientific title
Post-dural puncture headache following lumbar puncture with/without intrathecal chemotherapy, how long should patients remain recumbent? A pilot randomised controlled trial (The PLANE Study)
Secondary ID [1] 297099 0
Nil known.
Universal Trial Number (UTN)
U1111-1226-8483
Trial acronym
The PLANE Study
Linked study record
Not Applicable

Health condition
Health condition(s) or problem(s) studied:
Post-dural puncture headache 311113 0
Condition category
Condition code
Cancer 309743 309743 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 310067 310067 0 0
Leukaemia - Acute leukaemia
Cancer 310068 310068 0 0
Hodgkin's
Neurological 310180 310180 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a parallel group, pragmatic pilot randomised controlled trial where participants scheduled for either a diagnostic or therapeutic lumbar puncture will be randomised to either less than or equal to 1 hour lying supine following a lumbar puncture with/without intrathecal chemotherapy or to 2 hours lying supine (current practice) following a lumbar puncture with/without intrathecal chemotherapy and monitored for patient reported symptoms of post-dural puncture headache. Randomisation will be via a telephone-based service to conform with best practice standards for randomisation generation and allocation concealment until study entry. Randomisation will be on a 1:1 ratio between groups with randomly varied block sizes. A Research Nurse, who has undertaken Good Clinical Practice training, will screen and gain consent from patients scheduled for a lumbar puncture within Cancer Care Services at the Royal Brisbane and Women's Hospital, Herston, Queensland. A Registered Nurse will perform all nursing assessments and care leading up to, during and following the patient's lumbar puncture. A Research Nurse will conduct a follow-up assessment either by telephone or in person 48 hours after the lumbar puncture.

Clarification: Patients are required to remain lying flat for the prescribed time, ie. either 1 hour or 2 hours. If patients indicate that they need to void, either a bottle or pan would be employed to facilitate this. Should patients insist on being upright to void, they would be advised of the potential risk of headache, escorted to and from the bathroom, and closely monitored on return to bed. This would be recorded as a deviation to the protocol. Furthermore, this approach would be applied should the patient indicate they need to vomit or move for any other purpose. Patients will be allowed to watch TV while lying flat, use their mobile phones and verbally interact with carers/staff.

No video recording will be taken of patients during their period of lying supine. The procedure will be carried out in the Oncology Day Therapy Unit of Royal Brisbane and Women's Hospital. On completion of the lumbar puncture with/without intrathecal chemotherapy, patients will be monitored by the nurse attending to them and details regarding time of lumbar puncture, time of mobilisation, symptom monitoring and neurological observations undertaken as per hospital policy.
Intervention code [1] 313371 0
Prevention
Comparator / control treatment
The comparator/control treatment is where the patient is required to remain lying flat for a period of two (2) hours following a lumbar puncture with/without intrathecal chemotherapy.
Control group
Active

Outcomes
Primary outcome [1] 318706 0
The feasibility of conducting a randomised controlled trial to evaluate prevalence and/or severity of post-dural puncture headache in patients after lying supine for either one (1) hour or less versus greater than one (1) hour following lumbar puncture with/without intrathecal chemotherapy.

Analysis of feasibility will be based on the following measures:

(i) Recruitment: Greater than or equal to 80% of eligible patients agree to enrol;
(ii) Retention and attrition: Less than 15% of participants are lost to follow-up or withdraw from study;
(iii) Protocol adherence: Greater than or equal to 80% of participants receive their allocated treatment throughout their study participation;
(iv) Missing data: Less than 10% of data are missed during study data collection;
(v) Satisfaction and acceptability: to patients, carers and healthcare staff levels; and
(vi) Sample size estimates: For future equivalence trial.

Timepoint [1] 318706 0
At one (1) year after randomisation.
Secondary outcome [1] 365781 0
The presence of post-dural puncture headache following lumbar puncture with/without intrathecal chemotherapy collected dichotomously as "yes/no".
Timepoint [1] 365781 0
On completion of lumbar puncture with/without intrathecal chemotherapy through to completion of 48-hour follow-up (either by telephone or in person).
Secondary outcome [2] 366900 0
Severity of post-dural puncture headache experienced and onset. Using 11-point Likert scale for pain severity (No = 0).
Timepoint [2] 366900 0
Data collection of symptoms experienced and onset assessed following lumbar puncture, mobilisation and at 48-hour follow-up.
Secondary outcome [3] 366901 0
Patient satisfaction as reported by patient using a standardised tool. Questions asked are as follows:

1. How satisfied are you with the level of education you received regarding your lumbar puncture today?

2. How satisfied are you with the environment in which your lumbar puncture was performed?

3. How satisfied are you with the length of time required to complete your treatment including recovery time?

4. How satisfied are you with the information provided on caring for yourself at home following a lumbar puncture?

5. How satisfied are you with knowing how to manage complications following a lumbar puncture?

Responses to questions are graded using a Likert 5-point scale, as follows:

? Very Satisfied
? Satisfied
? Neutral
? Unsatisfied
? Very Unsatisfied
Timepoint [3] 366901 0
One (1) month post-lumbar puncture.

Eligibility
Key inclusion criteria
Haematology inpatients and outpatients requiring a lumbar puncture for either diagnostic and/or therapeutic purposes.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Language or cognitive barrier to consent.
ii) Pregnant women
iii) Under 18 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A Research Nurse (ReN) will screen and gain consent from inpatients and outpatients requiring LP within Cancer Care Services in Outpatients Procedure Unit (OPU), Oncology Day Therapy Unit (ODTU) and Ward 5C – Haematology and HSCT Unit. Randomisation will be via a telephone-based service to conform with best practice standards for randomisation generation and allocation concealment until study entry.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be on a 1:1 ratio between groups with randomly varied block sizes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12926 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 25401 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 301666 0
Hospital
Name [1] 301666 0
Royal Brisbane and Women's Hospital
Address [1] 301666 0
Corner Butterfield Street and
Bowen Bridge Road
HERSTON QLD 4029
Country [1] 301666 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Corner Butterfield Street and
Bowen Bridge Road
HERSTON QLD 4029
Country
Australia
Secondary sponsor category [1] 301385 0
None
Name [1] 301385 0
Address [1] 301385 0
Country [1] 301385 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302386 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 302386 0
Executive Suites, Lower Ground Floor,
Dr James Mayne Building,
Butterfield Street,
HERSTON QLD 4029
Ethics committee country [1] 302386 0
Australia
Date submitted for ethics approval [1] 302386 0
23/11/2018
Approval date [1] 302386 0
14/01/2019
Ethics approval number [1] 302386 0
HREC/2018/QRBW/48745

Summary
Brief summary
At the Royal Brisbane and Women's Hospital, Herston, Queensland, Australia, procedure mandates that patients lie flat for two (2) hours following a lumbar puncture (LP) with or without intrathecal chemotherapy. Most research to date has examined the prevalence of post-dural puncture headache (PDPH) and the length of time a patient needs to lie flat following an LP in non-cancer settings, with limited research examining patients in a cancer setting following intrathecal chemotherapy via LP. It is not clear if time spent lying flat impacts on outcomes such as patient reported PDPH and its severity. Some medical facilities within Australia and overseas have patients lying flat for one (1) hour. However, there is minimal evidence to support this practice. This research seeks to compare the practice of patients lying flat for one (1) hour versus two (2) hours following an LP with/without intrathecal chemotherapy and the prevalence of PDPH.

Who is it for?

You may be eligible for this study if you are an adult with a haematological cancer diagnosis who requires lumbar puncture for either diagnostic or therapeutic purposes.

Study details

As a participant in this study, you will be randomly allocation to either lying flat on your back for 1 hour or two hours after your lumbar puncture.

Routine bloods tests will be performed prior to your lumbar puncture. At the time of lumbar puncture cerebral spinal fluid will be collected for pathology. This is considered standard care and these tests do not form part of the research project.

It is hoped that this research will help determine whether one or two hours of lying down is more beneficial in reducing post-dural puncture headaches.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90054 0
Ms Veronica Percival
Address 90054 0
Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Corner Butterfield Street and
Bowen Bridge Road
HERSTON QLD 4029
Country 90054 0
Australia
Phone 90054 0
+61 7 36465833
Fax 90054 0
+61 7 36465832
Email 90054 0
veronica.percival@health.qld.gov.au
Contact person for public queries
Name 90055 0
Ms Nicole Gavin
Address 90055 0
Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Corner Butterfield Street and
Bowen Bridge Road
HERSTON QLD 4029
Country 90055 0
Australia
Phone 90055 0
+61 7 36465833
Fax 90055 0
+61 7 36465832
Email 90055 0
nicole.gavin@health.qld.gov.au
Contact person for scientific queries
Name 90056 0
Ms Nicole Gavin
Address 90056 0
Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Corner Butterfield Street and
Bowen Bridge Road
HERSTON QLD 4029
Country 90056 0
Australia
Phone 90056 0
+61 7 36465833
Fax 90056 0
+61 7 36465832
Email 90056 0
nicole.gavin@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient confidentiality and privacy.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
No Results