Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT04636034
Status:
TERMINATED
Last Update Posted:
2022-06-10
First Post:
2020-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Ganglion Sphenopalatine Block Versus Placebo on Persistent Headache Following COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059387', 'term': 'Sphenopalatine Ganglion Block'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}], 'ancestors': [{'id': 'D001340', 'term': 'Autonomic Nerve Block'}, {'id': 'D009407', 'term': 'Nerve Block'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Recruitment failure', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-07', 'studyFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Analgesics used daily in the week following the SPG-block', 'timeFrame': 'During study period until completion of 1 week follow up', 'description': 'The use of analgesics during the week following the block as registered by the patient and the patient file.'}], 'primaryOutcomes': [{'measure': '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".', 'timeFrame': '30 minutes after block', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)', 'timeFrame': '30 minutes and 1 week after block', '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.'}, {'measure': 'Worst experienced pain in standing position (0-10 on a numercial rating scale, NRS)', 'timeFrame': 'During study period until completion of 1 week follow up', 'description': 'The worst experienced pain reported during the week following the block as registered by the patient.'}, {'measure': 'Average pain intensity (0-10 on a numercial rating scale, NRS)', 'timeFrame': 'During study period until completion of 1 week follow up', 'description': 'The average pain intensity reported during the week following the block as registered by the patient.'}, {'measure': 'Number of patients needing "rescue GSP-block"', 'timeFrame': 'At 1 week follow up', '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.'}, {'measure': '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.', 'timeFrame': '30 minutes after block', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Headache', 'Covid19', 'Sphenopalatine Ganglion Block', 'Persistent Headache Following COVID-19']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nPrimary 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".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* 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.\n* Onset of headache during or maximum 4 weeks after PCR-verified COVID-19 infection.\n* Headache must have persisted for at least 4 weeks following COVID-19 diagnosis.\n\nExclusion Criteria:\n\n* Patients who cannot cooperate to the study\n* Patients who does not understand or speak Danish\n* Allergy to the drugs used in the study\n* Has taken opioids within 12 hours prior to intervention\n* History of migraine or persistent headache before COVID-19 infection.\n* 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.'}, 'identificationModule': {'nctId': 'NCT04636034', 'briefTitle': 'The Effect of Ganglion Sphenopalatine Block Versus Placebo on Persistent Headache Following COVID-19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Bispebjerg and Frederiksberg'}, 'officialTitle': 'The Effect of Ganglion Sphenopalatine Block (SPG-block) Versus Placebo on Persistent Headache Following COVID-19 Infection: a Randomised, Blinded, Clinical Trial', 'orgStudyIdInfo': {'id': 'GSPB-COVID-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ropivacaine-Lidocaine', 'interventionNames': ['Procedure: Sphenopalatine Ganglion Block with Local Anesthetic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Procedure: Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)']}, {'type': 'SHAM_COMPARATOR', 'label': '"Sham"-block with Placebo', 'interventionNames': ['Procedure: "Sham"-block with Placebo (Isotone NaCl)']}], 'interventions': [{'name': 'Sphenopalatine Ganglion Block with Local Anesthetic', 'type': 'PROCEDURE', 'description': 'Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL', 'armGroupLabels': ['Ropivacaine-Lidocaine']}, {'name': 'Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)', 'type': 'PROCEDURE', 'description': 'Block performed with bilaterally inserted q-tips with isotone NaCl', 'armGroupLabels': ['Placebo']}, {'name': '"Sham"-block with Placebo (Isotone NaCl)', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['"Sham"-block with Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg and Frederiksberg Hospital, University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Christian S Meyhoff, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Bispebjerg and Frederiksberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Bispebjerg and Frederiksberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Mads Seit Jespersen', 'investigatorAffiliation': 'University Hospital Bispebjerg and Frederiksberg'}}}}