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)

Not Applicable

Completed

• Conditions: Post-dural puncture headache; Neurological - Other neurological disorders; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma; Cancer - Leukaemia - Acute leukaemia; Cancer - Hodgkin's

• Registration Number: ACTRN12619000255189
• Lead Sponsor: Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-20
• Study Completion: 2021-06-10
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Haematology inpatients and outpatients requiring a lumbar puncture for either diagnostic and/or therapeutic purposes.

Exclusion Criteria

i)Language or cognitive barrier to consent.
ii)Pregnant women
iii)Under 18 years.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>Analysis of feasibility will be based on the following measures:<br><br>(i)Recruitment: Greater than or equal to 80% of eligible patients agree to enrol;<br>(ii)Retention and attrition: Less than 15% of participants are lost to follow-up or withdraw from study;<br>(iii)Protocol adherence: Greater than or equal to 80% of participants receive their allocated treatment throughout their study participation;<br>(iv)Missing data: Less than 10% of data are missed during study data collection;<br>(v)Satisfaction and acceptability: to patients, carers and healthcare staff levels; and<br>(vi)Sample size estimates: For future equivalence trial.<br><br>[At one (1) year after randomisation.]