Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache

Status

Completed

Phase

Phase 4

Enrollment

29 participants (actual)

Sponsor

United States Naval Medical Center, San Diego · Fed

Design

Randomized · Double masking

Countries

Not stated

Start

Aug 2010

Primary completion

Apr 2014

Completion

Apr 2014

First posted

20 Mar 2015 (estimated)

Last update posted

1 Nov 2016 (estimated)

Conditions

Postdural Puncture Headache

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).

• Experimental

  Intravenous Cosyntropin Group A

  Cosyntropin 500 mcg in 1000cc Normal Saline

• Active comparator

  Epidural Blood Patch Group B

  Epidural Blood Patch and I000cc Normal Saline

1. Headache Pain Score

   Time frame · 1 day post procedure

   Registry description

   Numerical 0-10 (0 no pain, 10 worst pain)

2. Headache Pain Score

   Time frame · 3 days post procedure

   Registry description

   Numerical 0-10 (0 no pain, 10 worst pain)

3. Headache Pain Score

   Time frame · 7 days post procedure

   Registry description

   Numerical 0-10 (0 no pain, 10 worst pain)

No study cites this trial.