Post-Lumbar Puncture HeadachePhase 2/3NCT00373074
Epidural Blood Patch on the Resolution of Postdural Puncture Headache (PDPH)
A Phase 2/3 study testing Epidural Blood Patch in people with Post-Lumbar Puncture Headache, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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?" Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post-Lumbar Puncture Headache
- What is being tested?
- Epidural Blood Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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?"
Read the 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.
- Conditions
- Post-Lumbar Puncture Headache
- Being tested
- Epidural Blood Patch
- Keywords
- Spinal Puncture Headache
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Blood PatchOther
Use 15 cc of blood
Epidural Blood PatchOther
Inject 20 cc of blood into epidural space
Epidural Blood PatchOther
Inject 30 cc of autologous blood
| Study group | Role | What they receive |
|---|---|---|
| 15 cc | Active comparator | 15 cc of blood used for Epidural Blood Patch Receives: Other: Epidural Blood Patch |
| 20 cc | Active comparator | 20 cc of blood used for Epidural Blood Patch Receives: Other: Epidural Blood Patch |
| 30 cc | Active comparator | 30cc of blood used for Epidural Blood Patch Receives: Other: Epidural Blood Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The site of headache
Measured: After epidural puncture
Associated symptoms of headache
Measured: after epidural puncture
The severity of and the degree of functional impairment from the post-dural puncture headache
Measured: after epidural puncture
The back discomfort experienced before, during, and after injection of blood
Measured: before, during and after injection of blood
Complete or partial success at relieving headache
Measured: After blood patch
Secondary outcomes (6)
The circumstances of the unintentional dural puncture
Measured: during epidural placement
Type of delivery
Measured: during delivery
History of migraine headache
Measured: before epidural placement
The time to onset of headache
Measured: After epidural placement
Use of analgesics & other symptomatic medication
Measured: After post dural puncture headache
The duration from dural puncture to EBP (NB. must be 24 h to 120 h)
Measured: 24 to 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2008 (estimated)
- Study completionJul 2008
Why it stopped: Lack of subject population for PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Lumbar Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas C.K. Lam, M.D., Principal investigator, University of Texas Medical School at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373074
- Sponsor's protocol ID
- HSC-MS-06-0220
- Status last verified
- Nov 2020
- First submitted
- 5 Sep 2006
- Last updated
- 5 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00373074
- Acronym / sponsor ID
- HSC-MS-06-0220
- Conditions
- Post-Lumbar Puncture Headache
- Keywords
- Spinal Puncture Headache
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of subject population for PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Jul 2008 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15 cc | Active comparator | Other: Epidural Blood Patch15 cc of blood used for Epidural Blood Patch |
| 20 cc | Active comparator | Other: Epidural Blood Patch20 cc of blood used for Epidural Blood Patch |
| 30 cc | Active comparator | Other: Epidural Blood Patch30cc of blood used for Epidural Blood Patch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Blood PatchUse 15 cc of blood | Other | 15 cc |
| Epidural Blood PatchInject 20 cc of blood into epidural space | Other | 20 cc |
| Epidural Blood PatchInject 30 cc of autologous blood | Other | 30 cc |
Primary outcome
The site of headache
Time frame: After epidural puncture
Associated symptoms of headache
Time frame: after epidural puncture
The severity of and the degree of functional impairment from the post-dural puncture headache
Time frame: after epidural puncture
The back discomfort experienced before, during, and after injection of blood
Time frame: before, during and after injection of blood
Complete or partial success at relieving headache
Time frame: After blood patch
6 secondary outcomes
The circumstances of the unintentional dural puncture
Time frame: during epidural placement
Type of delivery
Time frame: during delivery
History of migraine headache
Time frame: before epidural placement
The time to onset of headache
Time frame: After epidural placement
Use of analgesics & other symptomatic medication
Time frame: After post dural puncture headache
The duration from dural puncture to EBP (NB. must be 24 h to 120 h)
Time frame: 24 to 120 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
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Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas C.K. Lam, M.D. principal investigator
University of Texas Medical School at Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Epidural Blood Patch in people with Post-Lumbar Puncture Headache, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The site of headache (time frame: After epidural puncture). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.