Postdural Puncture Headache Clinical Trial
Official title:
Changes in Cerebral Blood Flow (CBF) in Prone and Sitting Position Before and After GSP-block and Before and After Epidural Blood-patch: A Substudy of NCT03652714
NCT number | NCT03966547 |
Other study ID # | GSPB-2018-SUB |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2020 |
Est. completion date | October 2020 |
Verified date | November 2020 |
Source | University Hospital Bispebjerg and Frederiksberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this optional sub-study to GSPB-2018 (NCT03652714) is to evaluate the changes in cerebral blood flow (CBF) under different conditions to understand if postdural puncture headache is caused by changes in the cerebral blood flow and if treatment normalises that change.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2020 |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Study Population: Subjects who have consented to participate in GSPB-2018 will be approached for participation in this sub-study. Subjects who have consented to participate in GSPB-2018 are not required to participate in this sub-study. Inclusion Criteria: - Age > 18 years - Patients with postdural puncture headache defined as moderate to severe postural headache (VAS >= 30mm) after lumbar puncture or accidental dural puncture during epidural insertion with an onset within 3 days following the puncture. - Lack of headache remission within 1 day after dural puncture and after treatment with fluids, caffeine and paracetamol - Patients who have given their written informed consent for participation in the study and substudy after fully understanding the protocol content and limitations. Exclusion Criteria: - Patients who cannot cooperate to the study - Patients who does not understand or speak Danish - Allergy to the drugs used in the study - Has taken opioids within 12 hours prior to intervention - No possible transcranial window on transcranial doppler. If not possible to find a useable window to get measurement the patient will be excluded and replaced with another patient. |
Country | Name | City | State |
---|---|---|---|
Denmark | Bispebjerg and Frederiksberg Hospital, University of Copenhagen | Copenhagen | |
Denmark | Rigshospitalet, University of Copenhagen | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Bispebjerg and Frederiksberg |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Cerebral Blood Flow velcity (CBF) in supine versus upright position compared to effect of treatment. | Change in mean, minimum and maximum Cerebral Blood Flow velcity in cm/sec (CBF) in supine versus upright position compared to effect of treatment. | <1h before and 1 hour after each intervention | |
Primary | Comparison of paint rating (0-100 on a visual analogue scale, VAS) and Cerebral Blood Flow velocity (CBF) before and after each intervention. | Pain intensity measured with a pain rating (0-100mm on a visual analogue scale, VAS) in supine position and as worst experienced pain after the patient has been upright for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.
Cerebral Blood Flow velocity (CBF) measured as mean blood flow in cm/sec. |
<1h before and 1 hour after each intervention | |
Secondary | Change in Cerebral Blood Flow velocity (CBF) in supine position before and after interventions. | Changes in mean, minimum and maximum Cerebral Blood Flow velocity in cm/sec (CBF) before and after treatment. | <1h before and 1 hour after each intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03112720 -
Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache
|
Phase 3 | |
Suspended |
NCT02473276 -
2 Dose Neuraxial Morphine for Prevention of PDPH
|
Phase 4 | |
Completed |
NCT03652714 -
The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache
|
Phase 3 | |
Completed |
NCT02859233 -
Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache
|
N/A | |
Withdrawn |
NCT02181205 -
Sphenopalatine Ganglion Block for Post-Dural Puncture Headache
|
N/A | |
Completed |
NCT01977898 -
Incidence of Headache Following an Unintentional Dural Puncture
|
N/A | |
Completed |
NCT06394024 -
Examination of Postdural Puncture Headache Frequency, Predisposing Factors and Treatment
|
||
Completed |
NCT06380764 -
Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache
|
N/A | |
Terminated |
NCT02365909 -
Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)
|
Early Phase 1 | |
Completed |
NCT04910477 -
Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache
|
Phase 3 | |
Completed |
NCT05969119 -
Addition of Pyridostigmine to Conventional Management of Postdural Puncture Headache
|
Phase 4 | |
Completed |
NCT02150304 -
Aminophylline Prophylaxis For Postdural Puncture Headache
|
N/A | |
Not yet recruiting |
NCT04709029 -
Effect of Intravenous Versus Intrathecal Dexamethazone on Postdural Puncture Headache
|
N/A | |
Withdrawn |
NCT02517931 -
Sphenopalatine Ganglion Block for Postdural Puncture Headache in the Emergency Department
|
N/A | |
Recruiting |
NCT06271486 -
Pregabalin in Treatment of Postdural Puncture Headache
|
Phase 3 | |
Completed |
NCT00465166 -
Lumbar Spine Ultrasound of Patients With Previous Accidental Dural Puncture During Labour Epidural
|
N/A | |
Not yet recruiting |
NCT05212194 -
The Relationship Between Post Dural Puncture Headache and Joint Laxity
|
N/A | |
Completed |
NCT05777694 -
Postdural Punction Headache After Ceserian Section
|
N/A | |
Withdrawn |
NCT04515901 -
Spenopalatine Ganglion Block for Treatment of Post-dural Puncture Headaches
|
N/A | |
Completed |
NCT04892290 -
Sphenopalatine Ganglion Block for Postdural Puncture Headache
|