- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03159000
A Research Study of Greater Occipital Nerve Block as a Treatment for Acute Migraine Attacks
16. november 2021 oppdatert av: Thomas Jefferson University
Double-Blind, Placebo Controlled Trial of Greater Occipital Nerve Block for the Treatment of Migraine Attacks
Several observational studies have shown improvement in episodic migraine with the use of greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did not show a decrease in frequency of episodic or chronic migraine; however, there has never been a placebo controlled trial to investigate the efficacy of GONB as an acute treatment for headache, and there has been no determination of guidelines for selection of patients who would be most likely to respond to GONB.
In light of the above, the investigators propose a double-blind, placebo-controlled, randomized trial examining the use of GONB with lidocaine/bupivocaine in patients with an acute episodic migraine.
The results of this trial are expected to guide more appropriate therapeutic management of these participants and the optimal use of this procedure.
50 subjects will be entered into this study.
This study is being conducted at Thomas Jefferson University only.
Studieoversikt
Status
Tilbaketrukket
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Thomas Jefferson University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling the international classification of headache disorders (ICHD3b) criteria for episodic migraine, presenting to clinic with an acute episodic migraine reported as at least a moderate pain level not lasting longer than 7 days at the time of injection.
Exclusion Criteria:
- subjects who have received greater occipital nerve block (GONB) in the past, subjects who in their own or the investigator's opinion are unable to describe their symptoms, subjects who have are scheduled to receive injection of onabotulinum toxin A within 72 hours, subjects who are pregnant or lactating.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: GONB of lidocaine/bupivacaine
The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally.
The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection.
Subjects who are not improved after 2 hours will be allowed to use their abortive treatment.
|
1ml of a 50% 2% lidocaine and 50% 0.5% bupivacaine
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Placebo komparator: Placebo injection of 1/3 saline
The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion bilaterally.
The subject will remain in the office for 30 minutes after injection, and receive a questionnaire to be filled out at 10 and 30 minutes, and 2 and 24 hours post-injection.
Subjects who are not improved after 2 hours will be allowed to use their abortive treatment.
|
1ml of 1/3 saline
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of subjects experiencing headache improvement at 2 hours
Tidsramme: 2 hours
|
Headache intensity on 4 point pain scale from moderate or severe to mild or none
|
2 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of subjects experiencing headache improvement 10 minutes
Tidsramme: 10 minutes
|
Headache intensity on 4 point pain scale from moderate or severe to mild or none.
|
10 minutes
|
Percentage of subjects experiencing headache improvement at 30 minutes
Tidsramme: 30 minutes
|
Headache intensity on 4 point pain scale from moderate or severe to mild or none.
|
30 minutes
|
Percentage of subjects experiencing headache improvement at 1 hour
Tidsramme: 1 hour
|
Headache intensity on 4 point pain scale from moderate or severe to mild or none.
|
1 hour
|
Percentage of subjects experiencing headache improvement at 24 hours
Tidsramme: 24 hours
|
Headache intensity on 4 point pain scale from moderate or severe to mild or none.
|
24 hours
|
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 10 minutes
Tidsramme: 10 minutes
|
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
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10 minutes
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Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 30 minutes
Tidsramme: 30 minutes
|
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
|
30 minutes
|
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 1 hour
Tidsramme: 1 hour
|
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
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1 hour
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Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 2 hours
Tidsramme: 2 hours
|
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
|
2 hours
|
Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 24 hours
Tidsramme: 24 hours
|
Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
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24 hours
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: William B Young, MD, Thomas Jefferson University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2017
Primær fullføring (Forventet)
31. desember 2017
Studiet fullført (Forventet)
30. juni 2018
Datoer for studieregistrering
Først innsendt
26. april 2017
Først innsendt som oppfylte QC-kriteriene
16. mai 2017
Først lagt ut (Faktiske)
18. mai 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. november 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. november 2021
Sist bekreftet
1. november 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Hodepinelidelser, Primær
- Hodepine lidelser
- Migrene lidelser
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-arytmimidler
- Sentralnervesystemdepressiva
- Agenter fra det perifere nervesystemet
- Sensoriske systemagenter
- Bedøvelsesmidler
- Membrantransportmodulatorer
- Anestesimidler, lokal
- Spenningskontrollerte natriumkanalblokkere
- Natriumkanalblokkere
- Lidokain
- Bupivakain
Andre studie-ID-numre
- GON/WBY/003
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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