(BMJ, IF:30.223)Effect of therapeutic suggestions during general anaesthesia on postoperative pain and opioid use: multicentre randomised controlled trialNowak Hartmuth,Zech Nina,Asmussen Sven et al. Effect of therapeutic suggestions during general anaesthesia on postoperative pain and opioid use: multicentre randomised controlled trial.[J] .BMJ, 2020, 371: m4284.
OBJECTIVE 目的
To investigate the effect of therapeutic suggestions played to patients through earphones during surgery onpostoperative pain and opioid use.
研究術中耳機播放治療建議對術後疼痛和阿片類藥物使用的影響。
DESIGN 設計
Blinded randomised controlled study.
隨機雙盲對照研究。
SETTING 單位
Five tertiary care hospitals in Germany.
德國的五家三級護理醫院。
PARTICIPANTS 研究物件
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.
2018年1月至12月連續入選的400例患者中的385例，均在全身麻醉下接受手術1~3h。按方案分析，干預組191例，對照組194例。
INTERVENTION 干預
The intervention comprised an audiotape of background music and positive suggestions based onhypnotherapeutic 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.
干預包括背景音樂和基於催眠治療原理的積極建議的錄音帶，反覆播放20min，然後在全身麻醉期間透過耳機向患者靜音10min。對照組的患者被分配到一盤空白磁帶上。
MAIN OUTCOME MEASURES 主要觀察指標
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).
主要觀察指標為術後24h內患者自控鎮痛或護士自控鎮痛的阿片類藥物用量，按數字評分標準定期評定疼痛強度(0~10分，分數越高表示疼痛越嚴重)。
RESULTS 結果
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.
與對照組相比，干預組術後24h內阿片類藥物用量明顯減少(P=0.002)，嗎啡當量中位數為4 mg(四分位數範圍0~8)，嗎啡當量中位數為5.3(2~12)，效應大小(Cohen’s d)為0.36(95%可信區間0.16~0.56)。干預組術後需要阿片類藥物人數明顯減少(P=0.001)：干預組121例(63%，95%可信區間45%~70%)，對照組155例(80%，74%~85%)。需要治療以避免術後阿片類藥物的人數為6人。干預組在術後24小時內疼痛評分持續顯著降低，平均下降25%。沒有不良事件的報道。
CONCLUSIONS 結論
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.
在全麻期間透過耳機播放治療建議可以提供一種安全、可行、廉價的非藥物技術，以減少術後疼痛和阿片類藥物的使用，具有推廣應用的潛力。根據相當數量的病人對術中知覺的發現，外科醫生和麻醉師應該注意手術中的背景噪音和對話。
TRIAL REGISTRATION 試驗註冊
German Clinical Trial Register DRKS00013800.
德國臨床試驗註冊DRKS00013800。