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

Postdural Puncture Headache Clinical Trial

Official title:

The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache: a Blinded Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652714
• Other study ID #: GSPB-2018
• Status: Completed
• Phase: Phase 3
• Start date: September 19, 2018
• Est. completion date: September 9, 2019

Study information

• Verified date: September 2019
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Primary outcome is hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position 30 minutes after block.

If the patients in the timeframe of 1 hour to 1 week after block does not achieve remission (VAS <30mm while standing) they will be offered a "rescue GSP-block" defined as a new GSP-block with "open-label" local anesthetic and if continued lack of remission at least 1 hour thereafter then an epidural blood patch will be offered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 9, 2019
• Est. primary completion date: September 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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
• Postdural Puncture Headache
• Sphenopalatine Ganglion Block

Intervention

Procedure:
• Ganglion sphenopalatine block with local anesthetic
Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL.
• Ganglion sphenopalatine block with placebo
Block performed with bilaterally inserted q-tips with isotone NaCl

Locations

Country	Name	City	State
Denmark	Bispebjerg and Frederiksberg Hospital, University of Copenhagen	Copenhagen
Denmark	Rigshospitalet, University of Copenhagen	Copenhagen
Denmark	Rigshospitalet Glostrup, University of Copenhagen	Glostrup
Denmark	Herlev Hospital, University of Copenhagen	Herlev
Denmark	Nordsjællands Hospital Hillerød	Hillerød

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	Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position.	Pain intensity will be measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.	30 minutes after block
Secondary	Pain rating (0-100mm on a visual analogue scale, VAS) in standing position	Pain intensity measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.	1 hour after block and 1 week after block
Secondary	Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)	Pain intensity measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.	30 minutes after block
Secondary	Number of patients needing "rescue GSP-block"		During study period until completion of 1 week follow up
Secondary	Number of patients needing a epidural blood patch		During study period until completion of 1 week follow up
Secondary	Pain rating (0-100mm on a visual analogue scale, VAS) in supine position		30 minutes after block, 1 hour after block and 1 week after block