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

Primary Purpose

Headache, Covid19, Sphenopalatine Ganglion Block

Status

Terminated

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

Sphenopalatine Ganglion Block with Local Anesthetic

Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)

"Sham"-block with Placebo (Isotone NaCl)

About this trial

This is an interventional treatment trial for Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Sham Comparator

Arm Label

Ropivacaine-Lidocaine

Placebo

"Sham"-block with Placebo

Arm Description

Outcomes

Primary Outcome Measures

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".

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

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

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)

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)

The average pain intensity reported during the week following the block as registered by the patient.

Number of patients needing "rescue GSP-block"

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.

Full Information

NCT ID

NCT04636034

First Posted

November 18, 2020

Last Updated

June 7, 2022

Sponsor

University Hospital Bispebjerg and Frederiksberg

1. Study Identification

Unique Protocol Identification Number

NCT04636034

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Terminated

Why Stopped

Recruitment failure

Study Start Date

January 12, 2021 (Actual)

Primary Completion Date

June 6, 2022 (Actual)

Study Completion Date

June 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Bispebjerg and Frederiksberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ropivacaine-Lidocaine

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

"Sham"-block with Placebo

Arm Type

Sham Comparator

Intervention Type

Procedure

Intervention Name(s)

Sphenopalatine Ganglion Block with Local Anesthetic

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)

Intervention Description

Block performed with bilaterally inserted q-tips with isotone NaCl

Intervention Type

Procedure

Intervention Name(s)

"Sham"-block with Placebo (Isotone NaCl)

Intervention Description

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 Measure Information:

Title

Description

Time Frame

30 minutes after block

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

30 minutes and 1 week after block

Title

Worst experienced pain in standing position (0-10 on a numercial rating scale, NRS)

Description

The worst experienced pain reported during the week following the block as registered by the patient.

Time Frame

During study period until completion of 1 week follow up

Title

Average pain intensity (0-10 on a numercial rating scale, NRS)

Description

The average pain intensity reported during the week following the block as registered by the patient.

Time Frame

During study period until completion of 1 week follow up

Title

Number of patients needing "rescue GSP-block"

Description

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.

Time Frame

At 1 week follow up

Title

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.

Description

Time Frame

30 minutes after block

Other Pre-specified Outcome Measures:

Title

Analgesics used daily in the week following the SPG-block

Description

The use of analgesics during the week following the block as registered by the patient and the patient file.

Time Frame

During study period until completion of 1 week follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian S Meyhoff, PhD

Organizational Affiliation

University Hospital Bispebjerg and Frederiksberg

Official's Role

Study Director

Facility Information:

Facility Name

Bispebjerg and Frederiksberg Hospital, University of Copenhagen

City

Copenhagen

ZIP/Postal Code

2400

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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