Clinical Trial: A Randomized Study Evaluating the Incidence of Post Lumbar Puncture Headache With Atraumatic Needles in Hematology

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: SPPLAASH Study : a Randomized Study Aiming at Evaluating the Incidence of Post Lumbar Puncture Headache (PLPH) With the Use of Atraumatic Needles in Hematology

Brief Summary: Lumbar punctures are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. Post lumbar puncture headache is a common complication for patients and is characterized by the occurrence of a headache with an orthostatic component, with additional symptoms such as nausea. Some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for post lumbar puncture headache while using atraumatic needles as compared to standard needles. In this context, it is necessary to better document the incidence of post lumbar puncture headache with the use of atraumatic needles in hematologic patients.

Detailed Summary: Lumbar punctures (LP) are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. Post lumbar puncture headache (PLPH) is a common complication in around 30% of patients. PLPH is characterized by the occurrence of a headache with an orthostatic component within 12-72 hours after LP with additional symptoms such as nausea. Even if this phenomenon spontaneously resolves within 3 to 5 days, symptoms can immobilize the patient and can interfere with his daily activities. Technical procedures largely influence the incidence of PLPH. Indeed, some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for PLHP while using atraumatic needles as compared to standard needles. So far, few data are available for hematology. In this context, it is necessary to better document the incidence of PLPH with the use of atraumatic needles in hematologic patients.
Sponsor: Institut de Cancérologie de la Loire

Current Primary Outcome: Number of headache [ Time Frame: 5 days ]

Incidence of patients with mild and severe headache within 5 days following lumbar puncture as evaluated by verbal rating scales (intensity score ≥4) will be reported.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Intensity of headache [ Time Frame: 5 days ]
    Maximum intensity of headache as evaluated by verbal rating scale (scoring from 0 to 10) within 5 days following lumbar puncture will be reported for each patient.
  • Duration of significant headache [ Time Frame: 5 days ]
    Duration in days of mild and severe headache (verbal rating scale score ≥ 4) within 5 days following lumbar puncture will be reported for each patient.
  • Pain intensity [ Time Frame: 5 days ]
    Local and immediate Intensity Pain during lumbar puncture will be reported for each patient. Intensity is evaluated by verbal rating scale.


Original Secondary Outcome: Same as current

Information By: Institut de Cancérologie de la Loire

Dates:
Date Received: April 20, 2017
Date Started: May 2017
Date Completion: December 2019
Last Updated: April 20, 2017
Last Verified: April 2017