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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 : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
Mads Seit Jespersen, University Hospital Bispebjerg and Frederiksberg

Tracking Information
First Submitted Date  ICMJE November 18, 2020
First Posted Date  ICMJE November 19, 2020
Last Update Posted Date April 29, 2022
Actual Study Start Date  ICMJE January 12, 2021
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2020)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: November 18, 2020)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Ganglion Sphenopalatine Block Versus Placebo on Persistent Headache Following COVID-19 Infection
Official Title  ICMJE The Effect of Ganglion Sphenopalatine Block (SPG-block) Versus Placebo on Persistent Headache Following COVID-19 Infection: a Randomised, Blinded, Clinical Trial
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.
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".

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Headache
  • Covid19
  • Sphenopalatine Ganglion Block
  • Persistent Headache Following COVID-19
Intervention  ICMJE
  • 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
  • Procedure: Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)
    Block performed with bilaterally inserted q-tips with isotone NaCl
  • 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.
Study Arms  ICMJE
  • Experimental: Ropivacaine-Lidocaine
    Intervention: Procedure: Sphenopalatine Ganglion Block with Local Anesthetic
  • Placebo Comparator: Placebo
    Intervention: Procedure: Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)
  • Sham Comparator: "Sham"-block with Placebo
    Intervention: Procedure: "Sham"-block with Placebo (Isotone NaCl)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 18, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christian S Meyhoff, PhD 004538636237 christian.sylvest.meyhoff@regionh.dk
Contact: Mads S Jespersen, MD mads.seit.jespersen@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04636034
Other Study ID Numbers  ICMJE GSPB-COVID-2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mads Seit Jespersen, University Hospital Bispebjerg and Frederiksberg
Study Sponsor  ICMJE University Hospital Bispebjerg and Frederiksberg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christian S Meyhoff, PhD University Hospital Bispebjerg and Frederiksberg
PRS Account University Hospital Bispebjerg and Frederiksberg
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP