Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373074
Status:
WITHDRAWN
Last Update Posted:
2020-11-05
First Post:
2006-09-05
Brief Title:
Epidural Blood Patch on the Resolution of Postdural Puncture Headache PDPH
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of subject population for PI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Crawfords 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
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 Crawfords 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None