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

Sponsor

University Hospital Bispebjerg and Frederiksberg (Other)

Overall Status

Completed

CT.gov ID

NCT03652714

Collaborator

(none)

Enrollment

Locations

Arms

11.7

Actual Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postdural Puncture Headache Sphenopalatine Ganglion Block	Procedure: Ganglion sphenopalatine block with local anesthetic Procedure: Ganglion sphenopalatine block with placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 19, 2018

Actual Primary Completion Date :

Sep 2, 2019

Actual Study Completion Date :

Sep 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Local anesthetic	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.
Placebo Comparator: Isotonic NaCl	Procedure: Ganglion sphenopalatine block with placebo Block performed with bilaterally inserted q-tips with isotone NaCl

Arm

Intervention/Treatment

Experimental: Local anesthetic

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.

Placebo Comparator: Isotonic NaCl

Procedure: Ganglion sphenopalatine block with placebo

Block performed with bilaterally inserted q-tips with isotone NaCl

Outcome Measures

Primary Outcome Measures

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

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 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]
Number of patients needing a epidural blood patch [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Rigshospitalet, University of Copenhagen	Copenhagen	Denmark	2100
2	Bispebjerg and Frederiksberg Hospital, University of Copenhagen	Copenhagen	Denmark	2400
3	Rigshospitalet Glostrup, University of Copenhagen	Glostrup	Denmark	2600
4	Herlev Hospital, University of Copenhagen	Herlev	Denmark	2730
5	Nordsjællands Hospital Hillerød	Hillerød	Denmark	3400