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The Effect of Ganglion Sphenopalatine Block Versus Placebo on Persistent Headache Following COVID-19 Infection

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ClinicalTrials.gov Identifier: NCT04636034
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : January 14, 2021
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 (SPG block) on persistent headache following acute COVID-19 infection.

Condition or disease Intervention/treatment Phase
Headache Covid19 Sphenopalatine Ganglion Block Persistent Headache Following COVID-19 Procedure: Sphenopalatine Ganglion Block with Local Anesthetic Procedure: Sphenopalatine Ganglion Block with Placebo (Isotone NaCl) Procedure: "Sham"-block with Placebo (Isotone NaCl) Phase 3

Detailed Description:

Adult patients with persistent headache following COVID-19 infection will be enrolled in the study. The patients will be randomised into three groups; bilateral SPG-block withto receive local anesthetic (lidocaine + ropivacaine), bilateral SPG-block with placebo (isotone NaCl) or bilateral "sham"-block with 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 headache in standing position 30 minutes after block in the group Ropicavain-Lidocain and "sham".

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 (SPG-block) Versus Placebo on Persistent Headache Following COVID-19 Infection: a Randomised, Blinded, Clinical Trial
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Ropivacaine-Lidocaine Procedure: Sphenopalatine Ganglion 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: Placebo Procedure: Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)
Block performed with bilaterally inserted q-tips with isotone NaCl

Sham Comparator: "Sham"-block with Placebo Procedure: "Sham"-block with Placebo (Isotone NaCl)
Block performed with bilaterally inserted q-tips with isotone NaCl. The q-tips are inserted a maximum of 3 cm into the nasopharynx thus not reaching the mucus above the ganglion.




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 in the group Ropivacine-Lidocaine and "sham". [ 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. Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS) [ Time Frame: 30 minutes 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. Worst experienced pain in standing position (0-10 on a numercial rating scale, NRS) [ Time Frame: During study period until completion of 1 week follow up ]
    The worst experienced pain reported during the week following the block as registered by the patient.

  3. Average pain intensity (0-10 on a numercial rating scale, NRS) [ Time Frame: During study period until completion of 1 week follow up ]
    The average pain intensity reported during the week following the block as registered by the patient.

  4. Number of patients needing "rescue GSP-block" [ Time Frame: At 1 week follow up ]
    If the patient at the 1 week follow up still needs further treatment a "rescue SPG-block" defined as a new SPG-block with "open label" analgetics will be offered.

  5. Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position in all 3 groups. [ 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.


Other Outcome Measures:
  1. Analgesics used daily in the week following the SPG-block [ Time Frame: During study period until completion of 1 week follow up ]
    The use of analgesics during the week following the block as registered by the patient and the patient file.



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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
  • Moderate to severe headache (NRS >= 3) with self reported duration of minimum 6 hours during the past week as well as moderate to severe headache (NRS >= 3) on the day of intervention.
  • Onset of headache during or maximum 4 weeks after PCR-verified COVID-19 infection.
  • Headache must have persisted for at least 4 weeks following COVID-19 diagnosis.

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
  • History of migraine or persistent headache before COVID-19 infection.
  • Active COVID-19 infection (defined by the Danish Goverment regulations, i.e. 48 hours after last symptoms (omitting long term effects) or 7 days after positive COVID-19 test if no symptoms.

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): NCT04636034


Contacts
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Contact: Christian S Meyhoff, PhD 004538636237 christian.sylvest.meyhoff@regionh.dk
Contact: Mads S Jespersen, MD mads.seit.jespersen@regionh.dk

Locations
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Denmark
Bispebjerg and Frederiksberg Hospital, University of Copenhagen Recruiting
Copenhagen, Denmark, 2400
Contact: Christian S Meyhoff, PhD    004538636237    christian.sahlholt.meyhoff@regionh.dk   
Contact: Mads S Jespersen, MD       madsseitjespersen@gmail.com   
Sponsors and Collaborators
University Hospital Bispebjerg and Frederiksberg
Investigators
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Study Director: Christian S Meyhoff, PhD University Hospital Bispebjerg and Frederiksberg
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Responsible Party: Mads Seit Jespersen, MD, University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT04636034    
Other Study ID Numbers: GSPB-COVID-2020
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021

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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
Headache
Pain
Neurologic Manifestations
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents