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)

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.