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Clinical Trial Details — Status: Withdrawn

Administrative data

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Status Withdrawn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

Study information

Verified date November 2020
Source University Hospital Bispebjerg and Frederiksberg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn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.

Study Design


Intervention

Procedure:
Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018
Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL as per GSPB-2018.
Ganglion sphenopalatine block with placebo administered on study GSPB-2018
Block performed with bilaterally inserted q-tips with isotone NaCl as per GSPB-2018.

Locations

Country Name City State
Denmark Bispebjerg and Frederiksberg Hospital, University of Copenhagen Copenhagen
Denmark Rigshospitalet, University of Copenhagen Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Bispebjerg and Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

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
See also
  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
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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