Otolaryngology - Head & Neck Surgery, Johns Hopkins Medicine, Baltimore, Maryland, USA.
Department of Pain and Translational Symptom Science | Placebo Beyond Opinion Center, University of Maryland School of Nursing, Baltimore, Maryland, USA
BMJ Open. 2023 Jul 7;13(7):e069785. doi: 10.1136/bmjopen-2022-069785.
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.
由于疾病过程及其治疗的疼痛和心理社会后果，头颈部癌症患者术后有发生慢性阿片类药物依赖的巨大风险。条件性开放标签安慰剂（COLPs）已被证明在广泛的医疗条件下，可有效减少达到临床反应所需的活性药物剂量。我们假设与单独使用标准多模式镇痛相比，在头颈部癌症患者中，将 COLPs 加入标准多模式镇痛中，与基线相比，术后 5 天内的阿片类药物消耗将减少。
本随机对照试验将评估 COLP 在头颈部癌症患者辅助疼痛管理中的使用。参与者将按 1:1 随机分配到常规治疗组或 COLP 组。所有参与者将接受标准多模式镇痛，包括阿片类药物。COLP 组将另外接受 5 天的条件作用（即暴露于丁香油气味），同时给予活性和安慰剂阿片类药物。参与者将在术后 6 个月内通过调查完成疼痛、阿片类药物消耗和抑郁症状的评估。将比较两组术后第 5 天基线阿片类药物消耗的平均变化以及 6 个月的平均疼痛水平和阿片类药物消耗。
由于慢性阿片类药物依赖与该患者群体的生存率下降有关，因此对头颈部癌症患者术后疼痛管理更有效和更安全的策略仍有需求。该研究的结果可能为进一步研究 COLP 作为头颈部癌症患者辅助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（IRB00276225）的批准，并在国立卫生研究院临床试验数据库中注册。
NCT04973748。
