SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture

  • STATUS
    Recruiting
  • End date
    Dec 25, 2022
  • participants needed
    74
  • sponsor
    University Hospital, Toulouse
Updated on 25 January 2021
analgesics
morphine
aneurysm
headache
subarachnoid hemorrhage

Summary

Headache control is one of the major challenges in patients who suffered an acute aneurysmal subarachnoid hemorrhage (aSAH). Headache affects 90% of the patient and is resistant to the major pain medication. It results from the increased intracranial pressure and the inflammation caused by the accumulation of arterial blood in the subarachnoid space. Hemorrhagic cerebrospinal fluid (CSF) removal by a lumbar puncture (LP), is well tolerated, reduces intracranial pressure and accelerates the clearance of the blood products from CSF. Nonetheless it has never been tested in a randomized trial. The investigators aim to compare in patients who experienced a low grade aSAH, the variation of headache intensity after CSF removal by LP vs. Sham LP in addition to predefined analgesic protocol management.

Description

After aneurysmal subarachnoid hemorrhage (aSAH) almost 90 % of patients experience a severe headache during their hospital stay. Pain control often requires high doses of opioid drugs and sedation that remain only partially efficacious. In addition, there is to the investigator's knowledge currently no recommendation or consensus on aSAH related headache management. aSAH related headache results from the prolonged increased intracranial pressure and meningeal inflammation related to the accumulation of blood products in the subarachnoid space. Preliminary studies, suggest that hemorrhagic cerebrospinal fluid (CSF) removal by lumbar puncture (LP) or lumbar drain, is safe and decreases intracranial pressure. However its impact on headache control has never been tested. A reliable headache evaluation has to be performed among conscious patients experiencing a "low-grade" aSAH.

The objective of the study is to evaluate in patients experiencing low-grade acute aSAH (WFNS 1-3), the efficacy of CSF removal by LP vs. sham LP, on headache control. 74 patients with secured aneurysm by coiling, will be randomized (1:1) between day 3 and day 5 after aneurysmal rupture. The procedure will be performed in addition to a pre-specified antalgic protocol.

Mean headache intensity will be measured with the numeric verbal scale during the 24 hours before and the 24 hours after the procedure. The variation of mean intensity will be compared between the 2 groups.

The investigators hypothesize that this treatment may significantly decrease headache intensity after an aSAH. If this hypothesis is confirmed CSF removal by LP could be a simple cost effective and worldwide available strategy to improve

Details
Condition Headache, Pain, Subarachnoid Hemorrhage, Post-Surgical Pain, Pain (Pediatric), Headaches, aneurysmal subarachnoid hemorrhage
Treatment Lumbar puncture
Clinical Study IdentifierNCT03754335
SponsorUniversity Hospital, Toulouse
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age >18 years
Low grade subarachnoid hemorrhage (WFNS score between 1 and 3)
Aneurysmal rupture 5 days
Ruptured aneurysm secured by coiling since at least 48 h
Headache with a mean numeric verbal scale 4/10 during the last 24 hours
No contraindication for lumbar puncture
Affiliation to french social security
Person able to express her consent and to assess own headache intensity

Exclusion Criteria

Minor
Pregnancy, breastfeeding
Subarachnoid hemorrhage without aneurysm
Ruptured aneurysm not secured
High grade (WFNS 4 and 5) subarachnoid hemorrhage
Efficient anticoagulation
External ventricular drain placed before randomisation
People under legal protection
Participation to another research study with an ongoing disqualification period
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