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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02394457
Recruitment Status : Completed
First Posted : March 20, 2015
Results First Posted : November 1, 2016
Last Update Posted : November 1, 2016
Sponsor:
Collaborator:
United States Naval Medical Center, Portsmouth
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego

Brief 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).


Condition or disease Intervention/treatment Phase
Postdural Puncture Headache Drug: Cosyntropin Procedure: Epidural Blood Patch Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache (PDPH)
Study Start Date : August 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
Drug Information available for: Cosyntropin

Arm Intervention/treatment
Experimental: Intravenous Cosyntropin Group A
Cosyntropin 500 mcg in 1000cc Normal Saline
Drug: Cosyntropin
Intravenous Drug Infusion over 1 hour and a half
Other Name: Tetracosactin

Active Comparator: Epidural Blood Patch Group B
Epidural Blood Patch and I000cc Normal Saline
Procedure: Epidural Blood Patch
Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel.
Other Name: Blood patch




Primary Outcome Measures :
  1. Headache Pain Score [ Time Frame: 1 day post procedure ]
    Numerical 0-10 (0 no pain, 10 worst pain)

  2. Headache Pain Score [ Time Frame: 3 days post procedure ]
    Numerical 0-10 (0 no pain, 10 worst pain)

  3. Headache Pain Score [ Time Frame: 7 days post procedure ]
    Numerical 0-10 (0 no pain, 10 worst pain)


Secondary Outcome Measures :
  1. Functioning Score [ Time Frame: 1 day post procedure ]
    Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete activities of daily living (ADLs)

  2. Functioning Score [ Time Frame: 3 day post procedure ]
    Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs

  3. Functioning Score [ Time Frame: 7 day post procedure ]
    Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394457


Sponsors and Collaborators
United States Naval Medical Center, San Diego
United States Naval Medical Center, Portsmouth
Investigators
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Principal Investigator: Steven Hanling, MD NavalMCSD Pain Center

Publications:
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Responsible Party: United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT02394457    
Other Study ID Numbers: NMCSD.2006.0026
First Posted: March 20, 2015    Key Record Dates
Results First Posted: November 1, 2016
Last Update Posted: November 1, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by United States Naval Medical Center, San Diego:
Postdural puncture headache
Epidural Blood Patch
Cosyntropin
PDPH
Regional anesthesia
Lumbar puncture
ACTH
Tetracosactin
Additional relevant MeSH terms:
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Post-Dural Puncture Headache
Headache
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cosyntropin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs