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

NCT04636034 | Terminated Phase 3 DMC

• 1 other identifier: GSPB-COVID-2020
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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".

  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.

  30 minutes after block

Secondary Outcomes (5)

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

  30 minutes and 1 week after block

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

  During study period until completion of 1 week follow up

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

  During study period until completion of 1 week follow up

• Number of patients needing "rescue GSP-block"

  At 1 week follow up

• 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.

  30 minutes after block

Other Outcomes (1)

• Analgesics used daily in the week following the SPG-block

  During study period until completion of 1 week follow up

Study Arms (3)

Ropivacaine-Lidocaine

EXPERIMENTAL

Procedure: Sphenopalatine Ganglion Block with Local Anesthetic

Placebo

PLACEBO COMPARATOR

Procedure: Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)

"Sham"-block with Placebo

SHAM COMPARATOR

Procedure: "Sham"-block with Placebo (Isotone NaCl)

Interventions

Sphenopalatine Ganglion Block with Local Anesthetic PROCEDURE

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

Ropivacaine-Lidocaine

Sphenopalatine Ganglion Block with Placebo (Isotone NaCl) PROCEDURE

Block performed with bilaterally inserted q-tips with isotone NaCl

Placebo

"Sham"-block with Placebo (Isotone NaCl) PROCEDURE

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.

"Sham"-block with Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Headache; COVID-19

Interventions

Sphenopalatine Ganglion Block; Anesthetics, Local

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Christian S Meyhoff, PhD

  University Hospital Bispebjerg and Frederiksberg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 19, 2020
• Study Start: January 12, 2021
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

DK (1)