Patient-centered results from a multicenter study of continuous peripheral nerve blocks and postamputation phantom and residual limb pain: secondary outcomes from a randomized, clinical trial. 

以患者為中心的連續(xù)周圍神經(jīng)阻滯和截肢后幻肢痛和殘肢痛多中心研究的結(jié)果：隨機(jī)臨床試驗(yàn)的次要結(jié)果

論文摘要

Introduction We previously reported that a 6-day continuous peripheral nerve block reduces established postamputation phantom pain. To provide patients and providers with the information to best inform treatment decisions, here we reanalyze the data and present the results in a more patient-centered format. We also provide information on patient-defined clinically relevant benefits to facilitate evaluation of available studies and guide future trial design. 

我們之前報(bào)道過，連續(xù) 6 天的周圍神經(jīng)阻滯可減少已發(fā)生的截肢后幻肢痛。為了向患者和提供治療者最好的治療決策信息，我們?cè)谶@里重新分析數(shù)據(jù)并更加以患者為中心的格式呈現(xiàn)結(jié)果。我們還提供有關(guān)患者定義的臨床相關(guān)益處的信息，以促進(jìn)現(xiàn)有研究的評(píng)估并指導(dǎo)未來的試驗(yàn)設(shè)計(jì)。

Methods  The original trial enrolled participants with a limb amputation and phantom pain who were randomized to receive a 6-day continuous peripheral nerve block(s) of either ropivacaine (n=71) or saline (n=73) in a double-masked fashion. Here we calculate the percentage of each treatment group that experienced a clinically relevant improvement as defined by previous studies as well as present what the participants of our study defined as small, medium, and large analgesic improvements using the 7-point ordinal Patient Global Impression of Change(PGIC) [1-2] scale. 

最初的試驗(yàn)招募了患有肢體截肢和幻肢痛的參與者，他們被隨機(jī)分配接受為期 6 天的連續(xù)外周神經(jīng)阻滯，其中包括羅哌卡因 (n=71) 或生理鹽水 (n=73)，以雙盲方式進(jìn)行。在這里，我們計(jì)算了每個(gè)治療組中經(jīng)歷了先前研究所定義的臨床相關(guān)改善的百分比，并使用患者整體印象變化量表（PGIC）呈現(xiàn)了我們研究的參與者所定義的小、中和大鎮(zhèn)痛改善。

Results Among patients who were given a 6-day ropivacaine infusion, 57% experienced at least a 2-point improvement on the 11-point numeric rating scale in their average and worst phantom pain 4weeks postbaseline as compared with 26% (p<0.001) for average and 25% (p<0.001) for worst pain in patients given a placebo infusion. At 4weeks, the percentage of participants rating their pain as improved was 53% for the active vs 30% for the placebo groups (95% CI 1.7 (1.1, 2.7), p=0.008). 在接受 6 天羅哌卡因輸注的患者中，基線后 4 周，57% 的患者在 11 點(diǎn)數(shù)字評(píng)分量表上的平均疼痛和最嚴(yán)重幻肢痛至少改善了 2 分，而接受安慰劑輸注的患者中，平均疼痛和最嚴(yán)重幻痛分別為 26% (p<0.001) 和 25% (p<0.001)。第 4 周時(shí)，認(rèn)為羅哌卡因組疼痛有所改善的參與者比例為 53%，而安慰劑組為 30%（95% CI 1.7 (1.1, 2.7)，p=0.008）

For all patients combined, the median (IQR) phantom pain Numeric Rating Scale improvements at 4weeks considered small, medium, and large were 2 (0–2), 3 (2– 5), and 5 (3–7), respectively. The median improvements in the Brief Pain Inventory interference subscale (0–70) associated with small, medium, and large analgesic changes were 8 (1–18), 22 (14–31), and 39 (26–47). 

對(duì)于所有患者，4 周時(shí)幻肢痛數(shù)字評(píng)定量表改善的中位數(shù) (IQR) 小、中、大分別為 2 (0-2)、3 (2-5) 和 5 (3-7)。與小、中、大鎮(zhèn)痛改變相關(guān)的簡(jiǎn)短疼痛量表干擾量表 (0-70) 的中位改善分別為 8 (1-18)、22 (14-31) 和 39 (26-47)。

Conclusions Among patients with postamputation phantom pain, a continuous peripheral nerve block more than doubles the chance of a clinically relevant improvement in pain intensity. Amputees with phantom and/or residual limb pain rate analgesic improvements as clinically relevant similarly to other chronic pain etiologies, although their smallest relevant improvement in the Brief Pain Inventory was significantly larger than previously published values. 

在截肢后幻肢痛患者中，持續(xù)周圍神經(jīng)阻滯使臨床相關(guān)疼痛強(qiáng)度改善的機(jī)會(huì)增加一倍以上。患有幻肢痛和/或殘肢痛的截肢者的鎮(zhèn)痛改善與其他慢性疼痛病因類似，具有臨床相關(guān)性，盡管他們?cè)诙虝禾弁戳勘碇械淖钚∠嚓P(guān)改善明顯大于之前公布的值。

結(jié)果展示

1. Among patients with any phantom pain at baseline who were given a 6-day ropivacaine infusion, 57% experienced at least a 2-point improvement on the 11-point numeric rating scale in their average and worst phantom pain 4weeks postbaseline as compared with 26% for average (relative risk (95%CI) of 1.6 (1.2, 2.1), p<0.001) and 25% for worst pain (relative risk (95%CI) of 1.8 (1.3, 2.7), p<0.001) in patients given a placebo infusion (figure 2). 

    Overall, active patients were an estimated 2 (95% CI 1.4, 4) times more likely to have a better change in average residual limb pain from baseline compared with placebo.

在基線時(shí)出現(xiàn)幻肢痛并給予 6 天羅哌卡因輸注的患者中，57% 的患者在基線后 4 周的平均幻痛和最嚴(yán)重幻痛的 11 點(diǎn)數(shù)字評(píng)分量表上至少改善 2 分，而平均水平（相對(duì)風(fēng)險(xiǎn) (95% CI) 為 1.6 (1.2, 2.1)，p<0.001）為 26%，最嚴(yán)重疼痛為 25%（相對(duì)風(fēng)險(xiǎn) (95% CI) 為 1.6 (1.2, 2.1)，p<0.001）。

總體而言，與安慰劑相比，活躍患者的平均殘肢疼痛較基線改善的可能性估計(jì)高出 2 倍（95% CI 1.4, 4）。

數(shù)據(jù)表示為中值（深色水平條），帶有 IQR（IQR，Q1 至 Q3）（框），最大值和 Q3+1.5×IQR 之間的最小值以及最小值和 Q1−1.5×IQR 之間的最大值（胡須）。散點(diǎn)代表數(shù)據(jù)點(diǎn)。氣泡上的數(shù)字代表治療組內(nèi)每個(gè)類別的百分比，基線時(shí)無疼痛的患者（紫色）除外，它表示受試者的實(shí)際數(shù)量。氣泡的大小與百分比/數(shù)量成正比。兩張圖均按改善程度進(jìn)行顏色編碼：無改善（紅色）、改善（橙色）和臨床相關(guān)改善（綠色）。

2. The percentage of patients experiencing a clinically relevant improvement in phantom and residual limb pain varied by their baseline pain intensity (tables 1 and 2). Patients beginning with severe pain (NRS >7) did not improve with active treatment versus placebo to the same degree as did participants with mild or moderate pain at baseline

幻肢痛和殘肢痛出現(xiàn)臨床相關(guān)改善的患者百分比因基線疼痛強(qiáng)度而異（表 1 和表 2）。與安慰劑相比，開始出現(xiàn)嚴(yán)重疼痛（NRS > 7）的患者在積極治療后的改善程度與基線時(shí)輕度或中度疼痛的參與者的改善程度不同。

3. Based on the PGIC at 4 weeks, the percentage of participants rating their pain as improved was 53% for the active vs 30% for the placebo groups (95% CI 1.7 (1.1 to 2.7), p=0.008). This indicates an individual was 74% more likely to experience self-described improvement in the active compared with the placebo group. The mean (SD) average phantom pain NRS improvements considered small, medium, and large by patients were 0.9 (1.9), 3 (1.8), and 5 (2.0), respectively (table 3). The corresponding median (IQR) were 2 (0–2), 3 (2–5), and 5 (3–7). 

4 周時(shí)的 PGIC，認(rèn)為活性藥物組疼痛有所改善的參與者百分比為 53%，而安慰劑組為 30%（95% CI 1.7（1.1 至 2.7），p=0.008）。這表明，與安慰劑組相比，個(gè)體在服用活性藥物后出現(xiàn)自我描述的改善的可能性要高

出 74%�；颊哒J(rèn)為小、中、大的幻痛 NRS 平均 (SD) 平均改善分別為 0.9 (1.9)、3 (1.8) 和 5 (2.0)（表 3）。相應(yīng)的中位數(shù) (IQR) 為 2 (0–2)、3 (2–5) 和 5 (3–7).

References

[1] Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001. 94(2): 149-158.

[2] Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004. 8(4): 283-91.

文章：差勁先生

排版：肉肉

       原文標(biāo)題 : 問：連續(xù)周圍神經(jīng)阻滯可以減少幻肢痛嗎？