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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-19

Study Completion Date

2019-09-09

Brief Summary

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

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Detailed Description

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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.

Conditions

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Postdural Puncture Headache Sphenopalatine Ganglion Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Local anesthetic

Group Type EXPERIMENTAL

Ganglion sphenopalatine block with local anesthetic

Intervention Type PROCEDURE

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

Isotonic NaCl

Group Type PLACEBO_COMPARATOR

Ganglion sphenopalatine block with placebo

Intervention Type PROCEDURE

Block performed with bilaterally inserted q-tips with isotone NaCl

Interventions

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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.

Intervention Type PROCEDURE

Ganglion sphenopalatine block with placebo

Block performed with bilaterally inserted q-tips with isotone NaCl

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No