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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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North Carolina
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Fort Bragg、North Carolina、アメリカ、28310
- Womack Army Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：Open label
Open label, no blinding, everyone receives Lazanda.
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Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Safety and Tolerability as Measured by the Number of Adverse Events
時間枠：24 hours
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Adverse events will be recorded by a yes or no as to their occurence
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24 hours
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool.
時間枠：Baseline, 15 min, 30 min, 45 min, and discharge
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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.
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Baseline, 15 min, 30 min, 45 min, and discharge
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Patient Satisfaction Using a Likert Satisfaction Survey
時間枠：24 hours
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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.
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24 hours
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Adverse Events
時間枠：24 hours
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Volunteers are monitored closely with vs, and sedation levels and any adverse issues will be recorded.
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24 hours
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Sedation Level Assessed by POSS Tool
時間枠：Baseline, 15 min, 30 min, 45 min, discharge
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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
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Baseline, 15 min, 30 min, 45 min, discharge
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協力者と研究者
協力者
捜査官
- 主任研究者：Michael W. Bartoszek, MD、Womack Army Medical Center IPMC
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。