Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
PDPH is a common problem after either intentional or unintentional Dural puncture. It is
especially common in young female patients and in patients undergoing Lumbar Puncture using
the typical kit containing large 20 gauge needles (1).
Hypothesis is that Cosyntropin therapy is at least as effective as current conservative
therapy (caffeine/fluid) and/or Epidural Blood Patch.
Patients will be randomly assigned to undergo either: (1) EBP with IVF therapy or
(2)Cosyntropin IV with IVF therapy. Endpoints will be a pain score that is given prior to the
procedure, Emergency Department (ED) discharge pain score and post procedural day (PPD) day
1, day 3 and day 7 pain and functional levels. Patients in Cosyntropin arm of the study may
request crossover to EBP at anytime after a 24 hour assessment period is completed per
Standard of Care for treatment of PDPH, in order to ensure no undue distress is placed on the
patient in order to complete this study.
Current treatments consist primarily of non-invasive treatment with intravenous fluids and
caffeine therapy and invasive treatment by Epidural Blood Patch. Efficacy of Caffeine 300mg
IV bis in die (BID) x 1d doses is approximately 70% (2). However this therapy has been linked
to post-treatment seizures. EBP was originally thought to be 90% effective with repeat
treatment efficacy approaching >96%. However more recent studies by Taivainen et al (3) have
shown only a 61% rate of permanent cure. Additionally, EBP are contraindicated in patients
with signs of increased intra-cranial pressure (ICP), coagulation issues, signs/symptoms of
Central Nervous System (CNS) /systemic infection or local infection at the site of the EBP,
thus resulting in decreased utility. Complications are also quite serious ranging from
meningitis, spinal hematoma, repeat dural puncture, localized infection and vagal response to
the procedure. EBP are not typically performed until after conservative measures have failed
which leads to further prolongation of the patients decreased functional status and pain.
Additionally, the cost of both treatments is substantial considering prolonged ED visits for
conservative treatments often followed by the time and expense of an EBP.
The goal of this investigation is to aid in the confirmation of case reports advocating the
economy, efficacy and safety of synthetic Adrenal CorticTropin Hormone (ACTH) as a treatment
of PDPH (4,5,6,7,8,9).