Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Knappschaftskrankenhaus, Ruhr University Bochum, Bochum, Germany.
Contributed equally.
BMJ. 2020 Dec 10;371:m4284. doi: 10.1136/bmj.m4284.
To investigate the effect of therapeutic suggestions played to patients through earphones during surgery on postoperative pain and opioid use.
Blinded randomised controlled study.
Five tertiary care hospitals in Germany.
385 of 400 patients consecutively recruited from January to December 2018 who were to undergo surgery for 1-3 hours under general anaesthesia. In the per protocol analysis 191 patients were included in the intervention group and 194 patients in the control group.
The intervention comprised an audiotape of background music and positive suggestions based on hypnotherapeutic principles, which was played repeatedly for 20 minutes followed by 10 minutes of silence to patients through earphones during general anaesthesia. Patients in the control group were assigned to a blank tape.
The main outcome was dose of opioid administered by patient controlled analgesia or nurse controlled analgesia within the first postoperative 24 hours, based on regular evaluation of pain intensity on a numerical rating scale (range 0-10, with higher scores representing more severe pain).
Compared with the control group, the intervention group required a significantly (P=0.002) lower opioid dose within 24 hours after surgery, with a median of 4.0 mg (interquartile range 0-8) morphine equivalents versus 5.3 (2-12), and an effect size (Cohen's d) of 0.36 (95% confidence interval 0.16 to 0.56). The number of patients who needed opioids postoperatively was significantly (P=0.001) reduced in the intervention group: 121 of 191 (63%, 95% confidence interval 45% to 70%) patients in the intervention group versus 155 of 194 (80%, 74% to 85%) in the control group. The number needed to treat to avoid postoperative opioids was 6. Pain scores were consistently and significantly lower in the intervention group within 24 hours after surgery, with an average reduction of 25%. No adverse events were reported.
Therapeutic suggestions played through earphones during general anaesthesia could provide a safe, feasible, inexpensive, and non-drug technique to reduce postoperative pain and opioid use, with the potential for more general use. Based on the finding of intraoperative perception by a considerable number of patients, surgeons and anaesthetists should be careful about background noise and conversations during surgery.
German Clinical Trial Register DRKS00013800.
探讨术中通过耳机向患者播放治疗建议对术后疼痛和阿片类药物使用的影响。
盲法随机对照研究。
德国五所三级保健医院。
2018 年 1 月至 12 月期间连续招募的 400 例拟行 1-3 小时全麻手术的患者中的 385 例。在符合方案分析中,191 例患者纳入干预组,194 例患者纳入对照组。
干预措施包括基于催眠治疗原则的背景音乐和积极建议的录音带,在全身麻醉期间通过耳机反复播放 20 分钟,然后静默 10 分钟。对照组患者被分配到空白录音带。
主要结局是术后 24 小时内患者自控镇痛或护士控制镇痛给予的阿片类药物剂量,根据数字评分量表(范围 0-10,得分越高表示疼痛越严重)定期评估疼痛强度。
与对照组相比,干预组术后 24 小时内阿片类药物剂量显著(P=0.002)降低,中位数为 4.0mg(四分位间距 0-8)吗啡当量,对照组为 5.3(2-12)吗啡当量,效应量(Cohen's d)为 0.36(95%置信区间 0.16 至 0.56)。术后需要阿片类药物的患者数量在干预组显著(P=0.001)减少:干预组 191 例患者中有 121 例(63%,95%置信区间 45%至 70%),对照组 194 例患者中有 155 例(80%,74%至 85%)。避免术后使用阿片类药物的所需人数为 6 人。术后 24 小时内,干预组疼痛评分持续且显著降低,平均降低 25%。未报告不良事件。
全麻期间通过耳机播放治疗建议可能是一种安全、可行、经济且非药物的技术,可减少术后疼痛和阿片类药物的使用,具有更广泛的应用潜力。基于相当数量患者术中感知的发现,外科医生和麻醉师应注意手术中的背景噪音和对话。
德国临床试验注册中心 DRKS00013800。