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

• ClinicalTrials.gov Identifier: NCT04636034
• Recruitment Status: Terminated
• First Posted: November 19, 2020
• Last Update Posted: June 10, 2022
• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Information provided by (Responsible Party): Mads Seit Jespersen, University Hospital Bispebjerg and Frederiksberg

Tracking Information

• First Submitted Date: November 18, 2020
• First Posted Date: November 19, 2020
• Last Update Posted Date: June 10, 2022
• Actual Study Start Date: January 12, 2021
• Actual Primary Completion Date: June 6, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: The Effect of Ganglion Sphenopalatine Block Versus Placebo on Persistent Headache Following COVID-19 Infection
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Headache
• Covid19
• Sphenopalatine Ganglion Block
• Persistent Headache Following COVID-19

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 7, 2022): 18
• Original Estimated Enrollment (submitted: November 18, 2020): 60
• Actual Study Completion Date: June 6, 2022
• Actual Primary Completion Date: June 6, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT04636034
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Mads Seit Jespersen, University Hospital Bispebjerg and Frederiksberg
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital Bispebjerg and Frederiksberg
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Christian S Meyhoff, PhD; University Hospital Bispebjerg and Frederiksberg

• PRS Account: University Hospital Bispebjerg and Frederiksberg
• Verification Date: June 2022