游离皮瓣患者的多模式疼痛研究
耳鼻喉科围手术期镇痛的多模式管理 - 头颈游离皮瓣重建手术:一项前瞻性研究
研究概览
详细说明
ABSTRACT
Objectives:
To apply implementation science principles to optimize the delivery of multimodal analgesia to patients undergoing major head and neck oncologic surgeries including free flap reconstruction, to reduce variability in opioid administration and decrease the need for opioids.
Methods:
A pilot prospective randomized controlled trial (RCT #1) followed by a hybrid type 1 effectiveness-implementation pragmatic randomized controlled trial (RCT #2).
RCT#1 included patients randomized to receive either scheduled acetaminophen and as needed opioids (control, Group 1) or scheduled acetaminophen, gabapentin, ketorolac, and as needed opioids (experimental, Group 2). The primary outcome was mean morphine milligram equivalents (MMEs) administered during the hospital stay. Secondary outcomes were hospital length of stay (LOS) and postoperative complications. We applied the principles of implementation science after identifying significant variability in healthcare professionals' approaches to administering opioids postoperatively during RCT#1.
RCT#2, a hybrid type 1 effectiveness-implementation pragmatic trial, was designed to test the effectiveness of the intervention and the penetrance of the implementation strategy. Arm A received standard regimen of scheduled acetaminophen and as needed opioids. Arm B received scheduled gabapentin, ketorolac, a regional nerve block at the free tissue donor site, scheduled acetaminophen and as needed opioids. Primary outcome was mean MMEs administered during the hospital stay (0-3 and 0-7 days). Secondary outcomes were LOS, complications, and functional pain scores (ABCs).
KEYWORDS: multimodal analgesia; head and neck; free flap reconstruction; dissemination and implementation
LEVEL OF EVIDENCE: 1B, Randomized Clinical Trial
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Kansas
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Kansas City、Kansas、美国、66160
- University of Kansas Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 在耳鼻喉科-头颈外科门诊就诊的 18 岁以上患者。
- 接受初次手术(游离皮瓣)进行癌症治疗的新 H&N 癌症诊断患者。
排除标准:
- 先前治疗过头颈癌。
- 计划用初级放射或化学放射治疗头颈癌。
- 孕妇或哺乳期妇女。
- 有持续或定期使用阿片类药物超过六个月的患者在术前使用过。
- 慢性加巴喷丁、普瑞巴林和其他非阿片类止痛药在术前使用。
- 诊断为纤维肌痛、焦虑症和其他疼痛综合征。
- 有肾脏或肝脏疾病病史的患者。
- 术前实验室检查值与肾脏/肝脏疾病有关的患者,例如肌酐升高或肝功能检查。
- 有严重胃肠道出血、CAD 或缺血性中风病史的患者。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:护理标准 A
随机对照前瞻性试验,比较头颈手术疼痛管理的两种护理标准。 A组,将包括:
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用于双臂,预定
用于双臂 PRN
用于双臂 PRN
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实验性的:护理标准 B
B组,将包括:
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用于双臂,预定
用于双臂 PRN
用于双臂 PRN
用于 B 臂
用于 B 臂
用于 B 臂 - 麻醉块
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Morphine Equivalents During Stay
大体时间:Duration of their initial post-operative hospital stay as defined as the interval between index surgery to post-operative day 7.
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Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.
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Duration of their initial post-operative hospital stay as defined as the interval between index surgery to post-operative day 7.
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Mean Morphine Equivalents
大体时间:From day of index surgery to 1 year post-operatively.
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Mean morphine equivalents prescribed outpatient after index surgery.
Will be calculated after converting all opioids to morphine equivalents and then averaging them.
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From day of index surgery to 1 year post-operatively.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Length of Stay
大体时间:At end of stay, number of post-operative days spent in the hospital was recorded for each patient.
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Length of stay in days
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At end of stay, number of post-operative days spent in the hospital was recorded for each patient.
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Number of Patients With Post-operative Complications
大体时间:Analyze the first 7 post-operative days to confirm number of patients with post-operative complications
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Monitor chart/EMR for bleeding, acute kidney injury, etc.
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Analyze the first 7 post-operative days to confirm number of patients with post-operative complications
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Patient Pain Percentage Compared to Baseline
大体时间:Pain level collected every 2 to 4 hours while inpatient. Daily pain percentage values were first averaged for each patient and then across all patients within each arm.
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Pain was measured on a Likert scale from 0 to 10 (i.e. 0 being the lowest and 10 being the greatest amount of pain). Baseline pain (P0) was measured on this scale for each patient in the preoperative setting. Pain was similarly assessed at regular intervals post-operatively during hospitalization (Pn). Patient pain percentage was subsequently defined as follows: { 100*[(P_n/P_0) -1]│ n∈N, n≥1} Where: P_0: the baseline (initial) measurement taken at time t=0. P_n: the measurement taken at the nth time interval after baseline, where n∈N, n≥1 Interpretation of "pain percentage compared to baseline":
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Pain level collected every 2 to 4 hours while inpatient. Daily pain percentage values were first averaged for each patient and then across all patients within each arm.
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Patient Pain Assessment Percentage
大体时间:Daily. The ABC pain scale will be given once daily for the patient to fill out for the first seven days.
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Each of the domain of ABC pain index is weighted (mult_D) based on relative importance. For each domain D ∈{sleep, lying, sitting, oob, walk}, let: D_able∈{1,2,3}, (1 = able with pain; 2 = unable due to pain; 3 = unable for other reasons) D_pain∈[0, 5] (reported pain score) Then if: D_able = 1 numerator_D = D_pain × mult_D denominator_D = 1 +(5×mult_D) D_able=2 numerator_D = 1 + (5×mult_D) denominator_D= 1 + (5×mult_D ) D_able=3 numerator_D = 1 denominator_D = 1 For the site-specific domains D ∈{h&n,flap,graft}, let: D_present∈{1,2} (1=present; 2=absent) D_pain∈[0, 5] (reported pain score) Then if: D_present=1: numerator_D = D_pain × mult_D denominator_D = 5 × mult_D D_present=2: numerator_D = 0 denominator_D = 0 Patient Pain Assessment Percentage: ABC_numerator = sum(numerator_D) ABC_denominator = sum(denominator_D) ABC_percentage = ABC_numerator / ABC_denominator This ranges from 0-100%. Lower values are better, higher values are worse. |
Daily. The ABC pain scale will be given once daily for the patient to fill out for the first seven days.
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合作者和调查者
调查人员
- 首席研究员:Lisa Shnayder, MD、KUMC
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
- 神经系统表现
- 神经系统疾病
- 按部位分类的肿瘤
- 肿瘤
- 神经行为表现
- 知觉障碍
- 病理状况、体征和症状
- 体征和症状
- 头颈肿瘤
- 失认症
- 氨基酸,肽和蛋白质
- 有机化学品
- 杂环化合物
- 杂环化合物,2环
- 杂环化合物,融合环
- 碳氢化合物
- 环己
- 环磷脂
- 碳氢化合物,Alicyclic
- 碳氢化合物,循环
- 酸,无环
- 羧酸
- 生物碱
- 多环芳烃
- 多环化合物
- Anilides
- 酰胺
- 苯胺化合物
- 胺
- 乙酰胺
- 放烟辛
- 吲哚
- 氨基酸
- 杂环化合物,4个或更多环
- γ-氨基丁酸
- Aminobutrates
- 丁酸酯
- 酸,碳环
- Morphinans
- 阿片类生物碱
- 杂环化合物,桥环
- 菲尼斯
- 吗啡衍生物
- 环己烷羧酸
- 可待因
- 加巴喷丁
- 布比卡因
- 对乙酰氨基酚
- 吗啡
- 酮咯酸氨丁三醇
- 羟考酮
其他研究编号
- 00025711
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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