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

Phase 3

Completed

• Conditions: Postdural Puncture Headache; Sphenopalatine Ganglion Block
• Interventions: Procedure: Ganglion sphenopalatine block with local anesthetic; Procedure: Ganglion sphenopalatine block with placebo

• Registration Number: NCT03652714
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-29
• Study Start: 2018-09-19
• Status Verified: 2019-09
• Primary Completion: 2019-09-02
• Study Completion: 2019-09-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local anesthetic	Ganglion sphenopalatine block with local anesthetic	-
Isotonic NaCl	Ganglion sphenopalatine block with placebo	-

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)	30 minutes after block	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.
Number of patients needing "rescue GSP-block"	During study period until completion of 1 week follow up
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
Pain rating (0-100mm on a visual analogue scale, VAS) in standing position	1 hour after block and 1 week after block	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.
Number of patients needing a epidural blood patch	During study period until completion of 1 week follow up

Trial Locations

Locations (5)

Rigshospitalet, University of Copenhagen; 🇩🇰 Copenhagen, Denmark

Rigshospitalet Glostrup, University of Copenhagen; 🇩🇰 Glostrup, Denmark

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

Herlev Hospital, University of Copenhagen; 🇩🇰 Herlev, Denmark

Nordsjællands Hospital Hillerød; 🇩🇰 Hillerød, Denmark