Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache
Condition: Postdural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache; Wounds and Injuries
Intervention: Cosyntropin; Epidural Blood Patch
Intervention description: Intravenous Drug Infusion over 1 hour and a half; Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel.
Intervention MeSH terms: Cosyntropin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Postdural puncture headache; Epidural Blood Patch; Cosyntropin; PDPH; Regional anesthesia; Lumbar puncture; ACTH; Tetracosactin

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).
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older,

          2. Diagnosed by Anesthesia provider as having PDPH

          3. Agrees to participation in study

        Exclusion Criteria:

          1. In-patient status and/or unstable medical condition

          2. Patient's contraindication to EBP: Local infection at injection site, systemic
             infection, hemodynamically unstable, severely hypovolemic

          3. Patient's contraindication to EBP: Known or past reaction to natural ACTH or
             Cosyntropin

          4. Signs or symptoms of ICP such as Mental Status changes, Bradycardia and hypertension

          5. Congestive Heart Failure

          6. Patient refusal to participate

          7. Current Pregnancy