Trials / Terminated
TerminatedNCT04636034
The Effect of Ganglion Sphenopalatine Block Versus Placebo on Persistent Headache Following COVID-19 Infection
The Effect of Ganglion Sphenopalatine Block (SPG-block) Versus Placebo on Persistent Headache Following COVID-19 Infection: a Randomised, Blinded, Clinical Trial
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- University Hospital Bispebjerg and Frederiksberg · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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".
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-01-12
- Primary completion
- 2022-06-06
- Completion
- 2022-06-06
- First posted
- 2020-11-19
- Last updated
- 2022-06-10
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04636034. Inclusion in this directory is not an endorsement.