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

NCT02394457 | Completed Phase 4 Results

• 1 other identifier: NMCSD.2006.0026
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Postdural Puncture Headache

Keywords

Postdural puncture headache; Epidural Blood Patch; Cosyntropin; PDPH; Regional anesthesia; Lumbar puncture; ACTH; Tetracosactin

Outcome Measures

Primary Outcomes (3)

• Headache Pain Score

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

  1 day post procedure

• Headache Pain Score

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

  3 days post procedure

• Headache Pain Score

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

  7 days post procedure

Secondary Outcomes (3)

• Functioning Score

  1 day post procedure

• Functioning Score

  3 day post procedure

• Functioning Score

  7 day post procedure

Study Arms (2)

Intravenous Cosyntropin Group A

EXPERIMENTAL

Cosyntropin 500 mcg in 1000cc Normal Saline

Drug: Cosyntropin

Epidural Blood Patch Group B

ACTIVE COMPARATOR

Epidural Blood Patch and I000cc Normal Saline

Procedure: Epidural Blood Patch

Interventions

Cosyntropin DRUG

Intravenous Drug Infusion over 1 hour and a half

Also known as: Tetracosactin

Intravenous Cosyntropin Group A

Epidural Blood Patch PROCEDURE

Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel.

Also known as: Blood patch

Epidural Blood Patch Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older,
• Diagnosed by Anesthesia provider as having PDPH
• Agrees to participation in study

You may not qualify if:

• In-patient status and/or unstable medical condition
• Patient's contraindication to EBP: Local infection at injection site, systemic infection, hemodynamically unstable, severely hypovolemic
• Patient's contraindication to EBP: Known or past reaction to natural ACTH or Cosyntropin
• Signs or symptoms of ICP such as Mental Status changes, Bradycardia and hypertension
• Congestive Heart Failure
• Patient refusal to participate
• Current Pregnancy

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead
• United States Naval Medical Center, Portsmouth: collaborator

Related Publications (7)

• VANDAM LD, DRIPPS RD. Long-term follow-up of patients who received 10,098 spinal anesthetics; syndrome of decreased intracranial pressure (headache and ocular and auditory difficulties). J Am Med Assoc. 1956 Jun 16;161(7):586-91. doi: 10.1001/jama.1956.02970070018005. No abstract available.

  PMID: 13318967 BACKGROUND

• Sechzer PH, Abel L. Post-spinal anesthesia headache treated with caffeine. Evaluation with demand method. Part I. Curr Therap Res 1978; 24:307-12.

  BACKGROUND

• Taivainen T, Pitkanen M, Tuominen M, Rosenberg PH. Efficacy of epidural blood patch for postdural puncture headache. Acta Anaesthesiol Scand. 1993 Oct;37(7):702-5. doi: 10.1111/j.1399-6576.1993.tb03793.x.

  PMID: 8249562 BACKGROUND

• Collier BB. Treatment for post dural puncture headache. Br J Anaesth. 1994 Mar;72(3):366-7. doi: 10.1093/bja/72.3.366-c. No abstract available.

  PMID: 8130064 BACKGROUND

• Foster P. ACTH treatment for post-lumbar puncture headache. Br J Anaesth. 1994 Sep;73(3):429. doi: 10.1093/bja/73.3.429-a. No abstract available.

  PMID: 7946882 BACKGROUND

• Carter BL, Pasupuleti R. Use of intravenous cosyntropin in the treatment of postdural puncture headache. Anesthesiology. 2000 Jan;92(1):272-4. doi: 10.1097/00000542-200001000-00043. No abstract available.

  PMID: 10638928 BACKGROUND

• Gupta S, Agrawal A. Postdural puncture headache and ACTH. J Clin Anesth. 1997 May;9(3):258. doi: 10.1016/s0952-8180(97)00042-1. No abstract available.

  PMID: 9172038 BACKGROUND

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Cosyntropin; Blood Patch, Epidural

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Adrenocorticotropic Hormone; Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Biological Therapy; Therapeutics; Injections, Epidural; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy

Limitations and Caveats

Subjects treated with cosyntropin could also receive EBP.Lack of description of patient activity level on follow up.Functional scoring tool not validated.Cost analysis \& system utilization not captured.Variations in clinical judgment.Lack of blinding

Results Point of Contact

• Title: Steven Hanling, MD
• Organization: Naval Medical Center San Diego

steven.r.hanling@mail.mil

619-532-8954

Study Officials

• Steven Hanling, MD

  NavalMCSD Pain Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 20, 2015
• Study Start: August 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 1, 2016
• Results First Posted: November 1, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share