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Completed

NCT Number: NCT05301387

The Effect of Ganglion Sphenopalatine Block (GSP-block) 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.

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Key information

Conditions

Post-Dural Puncture Headache Brain Diseases Central Nervous System Diseases Ganglion Sphenopalatine Block Headache Disorders Headache Disorders, Secondary Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ganglion Sphenopalatine Block

Procedure

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

Primary outcomes

  1. Migraine Disability Assessment Test score

    Time frame: 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+

  2. Average pain score

    Time frame: 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.

Secondary outcomes

  1. Migraine Disability Assessment Test score

    Time frame: 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+

  2. Average pain score

    Time frame: 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.

  3. Days with headache

    Time frame: 3 months following initial block as well as the last 3 months

    Number of days with headache

  4. Short term side effects

    Time frame: 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

  5. Long term side effects

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Registry information

Official study title

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

Acronym: GSP-FOLLOW

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2022
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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