Epidural Blood Patch on the Resolution of Postdural Puncture Headache (PDPH)

This study has been terminated.
(Lack of subject population for PI)
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00373074
First received: September 5, 2006
Last updated: February 4, 2009
Last verified: February 2009
  Purpose

The purpose of this study is to address the question, "What is the volume of blood for injection at epidural blood patch that most effectively relieves post-dural puncture headache?"


Condition Intervention Phase
Post-Lumbar Puncture Headache
Other: Epidural Blood Patch
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized Controlled Study Trial to Investigate the Effect of Varying Volumes of Blood Patch on the Resolution of Postdural Puncture Headache (PDPH)

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • The site of headache [ Time Frame: After epidural puncture ] [ Designated as safety issue: No ]
  • Associated symptoms of headache [ Time Frame: after epidural puncture ] [ Designated as safety issue: No ]
  • The severity of and the degree of functional impairment from the post-dural puncture headache [ Time Frame: after epidural puncture ] [ Designated as safety issue: No ]
  • The back discomfort experienced before, during, and after injection of blood [ Time Frame: before, during and after injection of blood ] [ Designated as safety issue: No ]
  • Complete or partial success at relieving headache [ Time Frame: After blood patch ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The circumstances of the unintentional dural puncture [ Time Frame: during epidural placement ] [ Designated as safety issue: No ]
  • Type of delivery [ Time Frame: during delivery ] [ Designated as safety issue: No ]
  • History of migraine headache [ Time Frame: before epidural placement ] [ Designated as safety issue: No ]
  • The time to onset of headache [ Time Frame: After epidural placement ] [ Designated as safety issue: No ]
  • Use of analgesics & other symptomatic medication [ Time Frame: After post dural puncture headache ] [ Designated as safety issue: No ]
  • The duration from dural puncture to EBP (NB. must be 24 h to 120 h) [ Time Frame: 24 to 120 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 0
Study Start Date: September 2006
Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 15 cc
15 cc of blood used for Epidural Blood Patch
Other: Epidural Blood Patch
Use 15 cc of blood
Active Comparator: 20 cc
20 cc of blood used for Epidural Blood Patch
Other: Epidural Blood Patch
Inject 20 cc of blood into epidural space
Active Comparator: 30 cc
30cc of blood used for Epidural Blood Patch
Other: Epidural Blood Patch
Inject 30 cc of autologous blood

  Hide Detailed Description

Detailed Description:

Accidental dural puncture is the most common (rate 1 in 50-250 in most obstetric hospitals) and, arguably, important complication of epidural insertion. After breach of the dura with a 16-18 gauge epidural needle in adult patients aged 18-60 years, the incidence of post-dural puncture headache (PDPH) is 80-90%. This headache is frequently severe or incapacitating, markedly postural and of at least several days duration. Associated symptoms include nausea and vomiting, auditory disturbance and ocular symptoms. PDPH often interferes with maternal -infant interaction by restricting or preventing ambulation and in some cases it confines the new mother to bed in a supine position. It is a significant cause of increased nursing and anaesthetic staff workload and of prolonged hospitalisation. Accidental dural puncture and PDPH may also rarely also be associated with other morbidity, such as cranial nerve palsy (III, IV, V, VI, VII, VIII) pain and dysaesthesia; and subdural haematoma. Fatalities have been reported following brainstem "coning" after prolonged low intracranial pressure headache. Untreated, the headache may become chronic and persist for months or even years.

The mechanism of PDPH is not clearly understood, although it is consistent with low intracranial pressure headache. Although imaging studies support that the precipitating event is loss of cerebrospinal fluid (CSF), the volume of loss is not directly related to the risk of headache. The change in intracranial CSF dynamics, with reduction of pressure, is considered more important. Reduction in CSF pressure may be influenced by a number of factors, including the volume of the lumbar subarachnoid CSF compartment, the rate of CSF loss and replenishment and the movement of CSF associated with patient positioning. The rate of change of intracranial CSF pressure may be more relevant than the specific pressure level, explaining the sudden onset of headache (mediated by vasodilation) when the patient assumes the upright position and hydrostatic forces redistribute intracranial CSF to the spinal CSF compartment.

Of procedural factors that are associated with failure of EBP, it is not clear whether the volume of blood injected is relevant. Despite 40 years of clinical use, it remains uncertain as to how much blood to inject and practice varies. An apparent relationship between volume and efficacy has been mooted, based mainly on the historical features of EBP. The injection of autologous blood was first suggested by Gormley in 1960, inspired by his impression (since shown to be erroneous) that dural puncture accompanied by "blood tap" was less likely to result in headache. He claimed 100% cure with 2-3 ml of blood injected into 8 patients. In 1970 and 1972 DiGiovanni et al described two series of 108 patients in total, for whom a larger volume of 5-10 ml of blood lead to permanent cure of 90%. In 1974, an average volume of 10 ml was said to have cured 182 of 185 patients, with volumes less than 10 ml appearing to be less successful. Taivainen et al could not detect any advantage with 15 ml versus 10 ml, the volume being chosen according to height of the patient. Crawford described his experience with EBP in 1980. He started with 6-15 ml of blood in 16 patients and reported a recurrence of PDPH within 2 days in a third of patients. A repeat EBP with 20 ml cured all 4 of these, leading him to change to routine administration of 20 ml. The next 100 patients received 17-20 ml, with 'total success' claimed in 80 of 83 given 20 ml. However, it is now known that such a high success rate may have reflected an inadequate duration and quality of follow-up. Crawford reviewed further experience with EBP in 1985, claiming that complete and permanent relief was achieved in 91% when 20 ml of blood was injected and 83% if lesser volumes were used. Crawford's influence was such that, during the past 20 years, this recommendation to use up to 20 ml of autologous blood has been established practice. Further support for the use of larger volumes of blood came from a series by Brownridge. He found that 10 ml or less of blood produced permanent relief in only 75%. In addition a clinical and imaging study by Szeinfeld et al. reported that an average of about 15 ml (range 12-18 ml) was successful and resulted in mean segmental spread of blood over 9 (range 7-14) spinal segments. In vitro, EBP is capable of tamponading up to 40 mm Hg of pressure after dural puncture with small spinal needles, although is less effective when a hole is made with a Tuohy needle. The mass effect of EBP disappears after a few hours, although focal clot may remain adherent to the dura within the subarachnoid space.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obstetric patients aged 18 or more years
  • Post-dural puncture headache (PDPH) after a confirmed or likely unintentional dural puncture with an epidural needle. PDPH is defined as " A headache with clear postural characteristics (onset or significant exacerbation when erect and relieved or significantly diminished by lying flat). The diagnosis is supported by distribution in the frontal or occipital region, with associated neck ache."
  • Medically suitable for and have consented to epidural blood patch (EBP) for treatment of PDPH

Exclusion Criteria:

  • Previous epidural blood patch (EBP) related to the same unintentionl dural puncture (including prophylactic EBP)
  • EBP to be performed more than 5 days after the unintentional dural puncture.
  • History of significant low or radicular back pain (requiring treatment) during pregnancy
  • Women in whom a further dural puncture occurs at the time of epidural needle insertion for the EBP
  • Diagnosis other than PDPH subsequently confirmed.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373074

Locations
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Nicholas C.K. Lam, M.D. University of Texas Medical School at Houston
  More Information

No publications provided

Responsible Party: Nicholas Lam, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00373074     History of Changes
Other Study ID Numbers: HSC-MS-06-0220
Study First Received: September 5, 2006
Last Updated: February 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Spinal Puncture Headache

Additional relevant MeSH terms:
Headache
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014