search
Back to results

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

Primary Purpose

Post-Lumbar Puncture Headache

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Epidural Blood Patch
Epidural Blood Patch
Epidural Blood Patch
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Lumbar Puncture Headache focused on measuring Spinal Puncture Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Hermann Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

15 cc

20 cc

30 cc

Arm Description

15 cc of blood used for Epidural Blood Patch

20 cc of blood used for Epidural Blood Patch

30cc of blood used for Epidural Blood Patch

Outcomes

Primary Outcome Measures

The site of headache
Associated symptoms of headache
The severity of and the degree of functional impairment from the post-dural puncture headache
The back discomfort experienced before, during, and after injection of blood
Complete or partial success at relieving headache

Secondary Outcome Measures

The circumstances of the unintentional dural puncture
Type of delivery
History of migraine headache
The time to onset of headache
Use of analgesics & other symptomatic medication
The duration from dural puncture to EBP (NB. must be 24 h to 120 h)

Full Information

First Posted
September 5, 2006
Last Updated
November 3, 2020
Sponsor
The University of Texas Health Science Center, Houston
search

1. Study Identification

Unique Protocol Identification Number
NCT00373074
Brief Title
Epidural Blood Patch on the Resolution of Postdural Puncture Headache (PDPH)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of subject population for PI
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2008 (Anticipated)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

5. Study Description

Brief Summary
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?"
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Lumbar Puncture Headache
Keywords
Spinal Puncture Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
15 cc
Arm Type
Active Comparator
Arm Description
15 cc of blood used for Epidural Blood Patch
Arm Title
20 cc
Arm Type
Active Comparator
Arm Description
20 cc of blood used for Epidural Blood Patch
Arm Title
30 cc
Arm Type
Active Comparator
Arm Description
30cc of blood used for Epidural Blood Patch
Intervention Type
Other
Intervention Name(s)
Epidural Blood Patch
Intervention Description
Use 15 cc of blood
Intervention Type
Other
Intervention Name(s)
Epidural Blood Patch
Intervention Description
Inject 20 cc of blood into epidural space
Intervention Type
Other
Intervention Name(s)
Epidural Blood Patch
Intervention Description
Inject 30 cc of autologous blood
Primary Outcome Measure Information:
Title
The site of headache
Time Frame
After epidural puncture
Title
Associated symptoms of headache
Time Frame
after epidural puncture
Title
The severity of and the degree of functional impairment from the post-dural puncture headache
Time Frame
after epidural puncture
Title
The back discomfort experienced before, during, and after injection of blood
Time Frame
before, during and after injection of blood
Title
Complete or partial success at relieving headache
Time Frame
After blood patch
Secondary Outcome Measure Information:
Title
The circumstances of the unintentional dural puncture
Time Frame
during epidural placement
Title
Type of delivery
Time Frame
during delivery
Title
History of migraine headache
Time Frame
before epidural placement
Title
The time to onset of headache
Time Frame
After epidural placement
Title
Use of analgesics & other symptomatic medication
Time Frame
After post dural puncture headache
Title
The duration from dural puncture to EBP (NB. must be 24 h to 120 h)
Time Frame
24 to 120 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas C.K. Lam, M.D.
Organizational Affiliation
University of Texas Medical School at Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs