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

Completed

• Conditions: Post-Dural Puncture Headache; Ganglion Sphenopalatine Block

• Registration Number: NCT05301387
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-11-25
• Study Start: 2021-11-26
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-03-29
• Status Verified: 2022-04
• Primary Completion: 2022-04-19
• Study Completion: 2022-04-19
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average pain score	3 months following initial block	Average pain score measured on a 0-10 pain rating scale (VAS) with 0 meaning no pain and 10 being the worst pain imaginable.
Migraine Disability Assessment Test score	3 months following initial block	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+

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bispebjerg and Frederiksberg Hospital, University of Copenhagen; 🇩🇰 Copenhagen, Denmark