Study protocol: randomised controlled trial of conditioned open-label placebo (COLP) for perioperative pain management in patients with head and neck cancer.
Study protocol: randomised controlled trial of conditioned open-label placebo (COLP) for perioperative pain management in patients with head and neck cancer.
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研究方案：针对头颈癌患者围手术期疼痛管理条件开放标签安慰剂（COLP）的随机对照试验。
DOI：
10.1136/bmjopen-2022-069785
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发表时间：
2023-07-07
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
--
作者：
头颈癌患者在手术后由于疾病过程及其治疗的疼痛和心理社会后果而具有慢性阿片类药物依赖的巨大风险。条件性开放标签安慰剂（COLP）可有效降低多种医学疾病临床应答所需的活性药物剂量。我们假设，在头颈部癌症患者中，与单独使用标准多模式镇痛相比，在标准多模式镇痛中添加COLP与术后5天基线阿片类药物消耗量减少相关。这项随机对照试验将评估COLP在头颈癌患者中用于持续性疼痛管理的应用。受试者将以1：1的比例随机分配至常规治疗组或COLP组。所有参与者将接受标准的多模式镇痛，包括阿片类药物。COLP组将额外接受5天的调节（即暴露于精油气味），并与活性和安慰剂阿片类药物配对。参与者将在手术后6个月内完成关于疼痛，阿片类药物消耗和抑郁症状的调查。将比较两组之间术后第5天基线阿片类药物消耗量的平均变化以及6个月内的平均疼痛水平和阿片类药物消耗量。对于头颈癌患者的术后疼痛管理，仍然需要更有效和更安全的策略，因为慢性阿片类药物依赖与该患者人群的生存率降低相关。这项研究的结果可能为进一步研究COLP作为头颈癌患者持续疼痛管理的策略奠定基础。该临床试验已获得约翰霍普金斯大学机构审查委员会（IRB 00276225）的批准，并在美国国立卫生研究院临床试验数据库中注册。NCT 04973748。
Patients with head and neck cancer have a substantial risk of chronic opioid dependence following surgery due to pain and psychosocial consequences from both the disease process and its treatments. Conditioned open-label placebos (COLPs) have been effective for reducing the dose of active medication required for a clinical response across a wide range of medical conditions. We hypothesise that the addition of COLPs to standard multimodal analgesia will be associated with reduced baseline opioid consumption by 5 days after surgery in comparison to standard multimodal analgesia alone in patients with head and neck cancer. This randomised controlled trial will evaluate the use of COLP for adjunctive pain management in patients with head and neck cancer. Participants will be randomised with 1:1 allocation to either the treatment as usual or COLP group. All participants will receive standard multimodal analgesia, including opioids. The COLP group will additionally receive conditioning (ie, exposure to a clove oil scent) paired with active and placebo opioids for 5 days. Participants will complete surveys on pain, opioid consumption and depression symptoms through 6 months after surgery. Average change in baseline opioid consumption by postoperative day 5 and average pain levels and opioid consumption through 6 months will be compared between groups. There remains a demand for more effective and safer strategies for postoperative pain management in patients with head and neck cancer as chronic opioid dependence has been associated with decreased survival in this patient population. Results from this study may lay the groundwork for further investigation of COLPs as a strategy for adjunctive pain management in patients with head and neck cancer. This clinical trial has been approved by the Johns Hopkins University Institutional Review Board (IRB00276225) and is registered on the National Institutes of Health Clinical Trials Database. NCT04973748.
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影响因子：
1.7
作者：
Arnstein, Paul;Gentile, Deborah;Wilson, Marian
通讯作者：
Wilson, Marian
影响因子：
9
作者：
Hill, Maureen V.;McMahon, Michelle L.;Barth, Richard J. Jr
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Barth, Richard J. Jr
影响因子：
3.3
作者：
Ader R;Mercurio MG;Walton J;James D;Davis M;Ojha V;Kimball AB;Fiorentino D
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Fiorentino D
影响因子：
3.7
作者：
Kaptchuk TJ;Friedlander E;Kelley JM;Sanchez MN;Kokkotou E;Singer JP;Kowalczykowski M;Miller FG;Kirsch I;Lembo AJ
通讯作者：
Lembo AJ
DOI：
10.1016/s1525-8610(04)70176-0
发表时间：
2001-05-01
影响因子：
7.6
作者：
Gloth, F M 3rd;Scheve, A A;Prosser, J
通讯作者：
Prosser, J