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游离皮瓣患者的多模式疼痛研究

2026年6月9日 更新者:University of Kansas Medical Center

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

这项研究将被设计为一项随机、前瞻性研究,比较疼痛管理组 A 和疼痛管理组 B。A 组将在围手术期按需使用泰诺和阿片类药物 (PRN)。 B 组将接受预定的加巴喷丁、酮咯酸和泰诺,以及管理区域神经阻滞的麻醉团队,在围手术期可使用阿片类药物进行 PRN。 将记录所有患者使用的止痛药量以及疼痛评分(0-10,其中 0 表示没有疼痛,10 表示有史以来最痛)以及整个患者住院期间的 ABC 疼痛评分. 在观察疼痛评分的同时,将计算每只手臂的阿片类药物的吗啡当量。 然后,研究人员将比较这两组,看看所使用的阿片类止痛药是否存在差异。 研究小组的假设是,联合使用加巴喷丁、酮咯酸和泰诺将显着减少(至少 30% 的平均吗啡当量 - MME)接受头颈部游离皮瓣重建的患者使用阿片类药物的情况与改善情况相似疼痛评分。

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

介入性

注册 (实际的)

30

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Kansas
      • Kansas City、Kansas、美国、66160
        • University of Kansas Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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:

  • 预定泰诺 1000 mg IV 一次,术中给药,然后通过 PEG 管或 PO Q4H 给药 650 mg,最大剂量为 4gm/24 小时
  • 基于数字疼痛量表(0-10,0 表示没有疼痛,10 表示有史以来最严重的疼痛)的阿片类药物 prn:
  • 0-3:不服用 prn 药物,放心,听音乐,看电视。
  • 4-7:羟考酮 5 mg q4h prn 通过 PEG 管或 PO 最多 30 mg/24 小时。
  • 8-10 吗啡 2 mg IV q2h prn 爆发性疼痛。
用于双臂,预定
用于双臂 PRN
用于双臂 PRN
实验性的:护理标准 B

B组,将包括:

  • 手臂 A 描述与附加..
  • 预定的酮咯酸从术后第 1 天开始,每 6 小时 15 毫克(最多 120 毫克/天),总共 5 天
  • 计划在术前 7 天开始服用加巴喷丁,以在术后继续
  • 根据麻醉方案进行区域阻滞 - 初始阻滞:0.5% 布比卡因,20 毫升 连续输注:0.125% 布比卡因,6 毫升/小时,每 30 分钟推注 5 毫升
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

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
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.
Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.
Duration of their initial post-operative hospital stay as defined as the interval between index surgery to post-operative day 7.
Mean Morphine Equivalents
大体时间:From day of index surgery to 1 year post-operatively.
Mean morphine equivalents prescribed outpatient after index surgery. Will be calculated after converting all opioids to morphine equivalents and then averaging them.
From day of index surgery to 1 year post-operatively.

次要结果测量

结果测量
措施说明
大体时间
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.
Length of stay in days
At end of stay, number of post-operative days spent in the hospital was recorded for each patient.
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
Monitor chart/EMR for bleeding, acute kidney injury, etc.
Analyze the first 7 post-operative days to confirm number of patients with post-operative complications
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.

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":

  • A value of 0% indicates no change from baseline pain
  • Negative values indicate lower pain than baseline
  • Positive values indicate higher pain than baseline
  • Therefore, lower values represent a better outcome and higher values represent a worse outcome
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.
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.

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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Lisa Shnayder, MD、KUMC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年11月1日

初级完成 (实际的)

2021年6月1日

研究完成 (实际的)

2023年5月1日

研究注册日期

首次提交

2019年10月31日

首先提交符合 QC 标准的

2020年1月28日

首次发布 (实际的)

2020年1月29日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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