- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02571634
Lazanda Fentanyl Nasal Spray Pre Radiofrequency Nerve Ablations(RFA) of Lumbar Facet Joints (RFA)
Open Label Feasibility Pilot Study to Assess the Efficacy and Safety of the Use of Lazanda for Anxiolysis During Radiofrequency Nerve Ablation of Lumbar Facet Joints
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The morning of the procedure/procedures the medication will be obtained from the omnicel by one of the qualified pain clinic study staff for the volunteers that have consented for that day. . It will be signed out on the designated form created for tracking and accountability purposes Patient consent for study participation will be confirmed.
Once in the procedure room a DVPRS (Defense and Veterans Pain Rating Scale) baseline pain score and POSS (Pasero Opioid-induced Sedation Scale) score will be assessed by a member of the research team. Baseline non-invasive blood pressure, heart rate, and oxygen saturation will be documented and continuous monitoring of these vital signs will commence by a provider credentialed by WAMC (Womack Army Medical Center) to perform anxiolysis with documentation every 15 minutes until discharge. A qualified RN (Registered Nurse), or physician will administer 100 mcg of Lazanda ten-fifteen minutes prior to the procedure The administration will be witnessed and confirmed on Appendix D. The unused 7 mcg will be wasted in a charcoal filled bag provided by the manufacturer and that bag will be disposed of per hospital policy. The waste will also be witnessed and noted. The Pasero Opioid-Induced Sedation Scale and a DVPRS pain score will be assessed every 15 minutes through the conclusion of the procedure and every 15 minutes up until discharge or for 1 hour post procedure whichever comes first. If naloxone is required during the procedure this will be noted as well. Any adverse or serious adverse events will be reported per regulatory regulations.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
-
-
North Carolina
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Fort Bragg, North Carolina, Vereinigte Staaten, 28310
- Womack Army Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Male and female patients ASA(American Society of Anesthesiologist physical classification system) I-III
- 18 years of age and older Referred for lumbar facet RFA (radio-frequency ablation) by Womack IPMC (Interdisciplinary Pain Management Center)
Exclusion Criteria:
- Known allergy to Fentanyl or naloxone
- Diagnoses of allergic rhinitis with active rhinorrhea
- Pregnant or Breastfeeding
- Asthma or COPD (chronic obstructive pulmonary disease) that requires frequent rescue medications.
- Hepatic insufficiency with abnormal liver enzymes
- Noted decreased mental function
- Heart rate under 50 or BP below 90 systolic and/or 60 diastolic
- Myasthenia gravis diagnoses
- Acute narrow angle glaucoma
- Allergy to meperidine
- On medications with a known dangerous drug interactions to Fentanyl
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: Open label
Open label, no blinding, everyone receives Lazanda.
|
Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Safety and Tolerability as Measured by the Number of Adverse Events
Zeitfenster: 24 hours
|
Adverse events will be recorded by a yes or no as to their occurence
|
24 hours
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool.
Zeitfenster: Baseline, 15 min, 30 min, 45 min, and discharge
|
DVPRS pain scores will be recorded baseline and at 15 minutes post dosing, 30 minutes, 45 minutes and discharge.
The DVPRS is a pain scale utilizing color coding descriptive terms and faces to describe pain levels from 0 meaning no pain and 10 the most excruciating pain ever.
|
Baseline, 15 min, 30 min, 45 min, and discharge
|
|
Patient Satisfaction Using a Likert Satisfaction Survey
Zeitfenster: 24 hours
|
At 24 hour after the procedure a call was made asking the volunteer to provide a number on a scale to describe their satisfaction with their pain control and their overall satisfaction.
A 5 point likert scale was used 1 = very satisfied, 2 satisfied, 3 neither satisfied nor dis-satisfied, 4 not satisfied and 5 very unsatisfied.
|
24 hours
|
|
Adverse Events
Zeitfenster: 24 hours
|
Volunteers are monitored closely with vs, and sedation levels and any adverse issues will be recorded.
|
24 hours
|
|
Sedation Level Assessed by POSS Tool
Zeitfenster: Baseline, 15 min, 30 min, 45 min, discharge
|
At baseline, 15 minutes post medication receipt, 30 minutes , 45 minutes and at discharge a Pasero-Opioid Sedation Scale Score was obtained.
This scale is to measure alertness and amount of sedation.
POSS was the abbreviated term used for this scale.
The guidelines for that scale include: S= sleeping easily aroused 1= alert and awake; 2= slightly drowsy easily aroused; 3= frequently drowsy, drifts off to sleep during conversation; 4= somnolent, minimal or no response
|
Baseline, 15 min, 30 min, 45 min, discharge
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Michael W. Bartoszek, MD, Womack Army Medical Center IPMC
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Schmerzen
- Neurologische Manifestationen
- Schmerz, prozedural
- Physiologische Wirkungen von Arzneimitteln
- Depressiva des zentralen Nervensystems
- Agenten des peripheren Nervensystems
- Analgetika
- Agenten des sensorischen Systems
- Anästhetika, intravenös
- Anästhesie, Allgemein
- Anästhetika
- Analgetika, Opioide
- Betäubungsmittel
- Adjuvantien, Anästhesie
- Fentanyl
Andere Studien-ID-Nummern
- 404457
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