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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652714
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Mads Seit Jespersen, 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.

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 19, 2018
Actual Primary Completion Date : September 2, 2019
Actual Study Completion Date : September 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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




Primary Outcome Measures :
  1. Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position. [ Time Frame: 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 :
  1. Pain rating (0-100mm on a visual analogue scale, VAS) in standing position [ Time Frame: 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.

  2. Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS) [ Time Frame: 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.

  3. Number of patients needing "rescue GSP-block" [ Time Frame: During study period until completion of 1 week follow up ]
  4. Number of patients needing a epidural blood patch [ Time Frame: During study period until completion of 1 week follow up ]
  5. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652714


Locations
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Denmark
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark, 2100
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
Copenhagen, Denmark, 2400
Rigshospitalet Glostrup, University of Copenhagen
Glostrup, Denmark, 2600
Herlev Hospital, University of Copenhagen
Herlev, Denmark, 2730
Nordsjællands Hospital Hillerød
Hillerød, Denmark, 3400
Sponsors and Collaborators
University Hospital Bispebjerg and Frederiksberg

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Responsible Party: Mads Seit Jespersen, MD, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT03652714    
Other Study ID Numbers: GSPB-2018
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ganglion Cysts
Synovial Cyst
Post-Dural Puncture Headache
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents