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

University Hospital Bispebjerg and Frederiksberg40 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postdural Puncture Headache Sphenopalatine Ganglion Block

Interventions

Ganglion sphenopalatine block with local anestheticPROCEDURE

Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL.

Ganglion sphenopalatine block with placeboPROCEDURE

Block performed with bilaterally inserted q-tips with isotone NaCl

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Rigshospitalet, University of Copenhagen

Copenhagen, Denmark

Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Copenhagen, Denmark

Rigshospitalet Glostrup, University of Copenhagen

Glostrup Municipality, Denmark

Herlev Hospital, University of Copenhagen

Herlev, Denmark

Outcomes

Primary Outcomes

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.

Time frame: 30 minutes after block

Secondary Outcomes

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.

Time frame: 1 hour after block and 1 week after block

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.

Time frame: 30 minutes after block

Number of patients needing "rescue GSP-block"

Time frame: During study period until completion of 1 week follow up

Number of patients needing a epidural blood patch

Time frame: During study period until completion of 1 week follow up

Pain rating (0-100mm on a visual analogue scale, VAS) in supine position

Time frame: 30 minutes after block, 1 hour after block and 1 week after block

Data from ClinicalTrials.gov

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