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

NCT05301387 | Completed DMC

• 1 other identifier: GSPB-2018-FOLLOW
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Dural Puncture Headache; Ganglion Sphenopalatine Block

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Migraine Disability Assessment Test score

  3 previous months

• Average pain score

  3 previous months

• Days with headache

  3 months following initial block as well as the last 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.

• 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.

Interventions

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were included in main study NCT03652714

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: March 29, 2022
• Study Start: November 26, 2021
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

DK (1)