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

Post-Dural Puncture Headache Clinical Trial

— GSP-FOLLOW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05301387
• Other study ID #: GSPB-2018-FOLLOW
• Status: Completed
• Start date: November 26, 2021
• Est. completion date: April 19, 2022

Study information

• Verified date: April 2022
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ganglion Cysts
• Headache
• Post-Dural Puncture Headache

Intervention

Procedure:
• Ganglion Sphenopalatine Block
Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL or Block performed with bilaterally inserted q-tips with isotone NaCl

Locations

Country	Name	City	State
Denmark	Bispebjerg and Frederiksberg Hospital, 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	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
Primary	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	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
Secondary	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
Secondary	Days with headache	Number of days with headache	3 months following initial block as well as the last 3 months
Secondary	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.
Secondary	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.