The Effect of Ganglion Sphenopalatine Block (GSP-block) Follow-Up (GSP-FOLLOW)

The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache: Follow Up

The purpose of this study is to evaluate the long term effects of the ganglion sphenopalatine block (GSP block) on postdural puncture headache.

Study Overview

• Status: Completed
• Conditions: Post-Dural Puncture Headache; Ganglion Sphenopalatine Block
• Intervention / Treatment: Procedure: Ganglion Sphenopalatine Block

Detailed Description

Adult patients with postdural puncture headache was enrolled in main study (NCT03652714). In the main study the patients was randomised to receive a ganglion sphenopalatine block (GSP-block) with either local anesthetic (lidocaine + ropivacaine) or placebo (isotone NaCl).

Following inclusion in the main study all participants are sent a follow-up questionnaire.

Primary outcome is disability due to headache defined as moderate to severe disability measured with Migraine Disability Assessment Test (MIDAS) in the 3 months following initial block and average pain score in the 3 months following the initial block on a 0-10 pain intensity scale.

Secondary outcome is disability due to headache defined as moderate to severe disability measured with Migraine Disability Assessment Test (MIDAS) in the 3 previous months as well as average pain scores in the previous 3 months, days with headache and long and short term side effects of the block.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who were included in main study NCT03652714

Description

Patients who where included in main study and had the following eligibility criteria:

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 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine Disability Assessment Test score	Disability due to headache defined as moderate to severe disability measured with Migraine Disability Assessment Test Score (MIDAS) ranging from no disability at a score of 0 to severe disability at a score of 21+	3 months following initial block
Average pain score	Average pain score measured on a 0-10 pain rating scale (VAS) with 0 meaning no pain and 10 being the worst pain imaginable.	3 months following initial block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine Disability Assessment Test score	Disability due to headache is defined as moderate to severe disability measured with Migraine Disability Assessment Test Score (MIDAS) ranging from no disability at a score of 0 to severe disability at a score of 21+	3 previous months
Average pain score	Average pain score measured on a 0-10 pain rating scale (VAS) with 0 meaning no pain and 10 being the worst pain imaginable.	3 previous months
Days with headache	Number of days with headache	3 months following initial block as well as the last 3 months
Short term side effects	Side effects following the block are defined as side effects with a duration of less than 3 months	From date of initial block application until time of questionaire and inclusion in follow up study, assessed up to 60 months.
Long term side effects	Side effects following the block defined as side effects with a duration of more than 3 months	From date of initial block application until time of questionaire and inclusion in follow up study, assessed up to 60 months.

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 26, 2021
• Primary Completion (ACTUAL): April 19, 2022
• Study Completion (ACTUAL): April 19, 2022

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (ACTUAL): March 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Pain; Neurologic Manifestations; Cysts; Connective Tissue Diseases; Mucinoses; Headache Disorders; Headache Disorders, Secondary; Headache; Ganglion Cysts; Synovial Cyst; Post-Dural Puncture Headache
• Other Study ID Numbers: GSPB-2018-FOLLOW

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No