Transcutaneous electrical acupoint stimulation before surgery reduces chronic pain after mastectomy: A randomized clinical trial
Transcutaneous electrical acupoint stimulation before surgery reduces chronic pain after mastectomy: A randomized clinical trial
复制标题
手术前经皮穴位电刺激可减轻乳房切除术后的慢性疼痛：一项随机临床试验
DOI：
10.1016/j.jclinane.2021.110453
复制
发表时间：
2021-07-13
影响因子：
6.7
通讯作者：
Xiong, Lize
中科院分区：
文献类型：
--
作者：
Lu, Zhihong;Wang, Qiang;Xiong, Lize
研究目的：尽管有多种干预措施，但乳房切除术后慢性疼痛的发生率可能高达50%。本研究旨在确定麻醉诱导前经皮穴位电刺激（TEAS）减轻慢性疼痛的效果，并比较联合穴位TEAS与单穴位TEAS的效果。设计：多中心随机临床试验。背景：本研究于2016年5月至2018年4月在中国的六家医学中心进行。最终随访时间为2018年10月26日。参与者：符合条件的患者是计划在全身麻醉下进行根治性乳房切除术的女性。干预措施：使用集中式计算机生成的随机化系统将患者随机平均分为假手术对照组（n = 188）、单穴位组（PC6，n = 198）或组合穴位组（PC6和CV17，n = 190）。麻醉诱导前应用TEAS 30 min。假手术对照组只贴附电极，不进行刺激。麻醉师、外科医生和结局评估员对干预措施不知情。测量：主要终点是术后6个月慢性疼痛的发生率。使用未校正的卡方检验比较各组之间的发生率。结果：在576例随机化患者中，568例完成了试验。在意向治疗分析中，190名患者中有42名报告了6个月时乳房切除术后疼痛联合取穴组65例（22.1%）假手术组为34.6%（P = 0.007;相对风险[RR]，95%置信区间[CI]：0.68，0.52-0.89），198例患者中有72例单穴组有效率为36.4%（P = 0.002; RR，95% CI：0.72，0.55 ~ 0.93）。联合穴位组术中瑞芬太尼用量及术后24 h恶心呕吐均低于假手术组。结论：术前联合穴位TEAS与术后6个月慢性疼痛减轻相关。试验注册：Clinicaltrials.gov标识符：NCT 02741726。2016年4月13日注册。
Study objective: Despite multiple interventions, the incidence of chronic pain after mastectomy could be as high as 50% after surgery. This study aimed to determine the efficacy of transcutaneous electrical acupoint stimulation (TEAS) before anesthesia induction in reducing chronic pain and to compare the effect of combined acupoint TEAS with that of single acupoint TEAS. Design: A multicenter randomized clinical trial. Setting: The study was conducted at six medical centers in China from May 2016 to April 2018. Final follow-up was on October 26, 2018. Participants: Eligible patients were women scheduled for radical mastectomy under general anesthesia. Interventions: Patients were randomly and equally grouped into sham control (n = 188), single acupoint (PC6, n = 198), or combined acupoints (PC6 and CV17, n = 190) TEAS groups using a centralized computer-generated randomization system. TEAS was applied for 30 min before anesthesia induction. The sham-operated control group received electrode attachment but without stimulation. Anesthesiologists, surgeons, and outcome assessors were blinded to the interventions. Measures: The primary endpoint was the incidence of chronic pain 6 months after surgery. Incidences were compared among the groups using the unadjusted chi 2 test. Results: Of the 576 randomized patients, 568 completed the trial. In the intention-to-treat analysis, postmastectomy pain at 6 months was reported in 42 of 190 patients (22.1%) in the combined acupoints group, 65 of 188 patients (34.6%) in the sham-operated group (P = 0.007; relative risk [RR], 95% confidence interval [CI]: 0.68, 0.52-0.89), and 72 of 198 patients (36.4%) in the single acupoint group (P = 0.002; RR, 95% CI: 0.72,0.55-0.93). Remifentanil consumption during surgery and postoperative nausea and vomiting at 24 h after surgery were lower in the combined acupoint group than that in the sham-operated group. Conclusion: TEAS at combined acupoints before surgery was associated with reduced chronic pain 6 months after surgery. Trial registration: Clinicaltrials.gov identifier: NCT02741726. Registered on April 13, 2016.