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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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North Carolina
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Fort Bragg, North Carolina, 미국, 28310
- Womack Army Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety and Tolerability as Measured by the Number of Adverse Events
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool.
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Michael W. Bartoszek, MD, Womack Army Medical Center IPMC
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 404457
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