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静脉注射利多卡因治疗创伤性肋骨骨折:一项双盲随机对照试验(INITIATE 研究计划)。

Intravenous lidocaine for the management of traumatic rib fractures: A double-blind randomized controlled trial (INITIATE program of research).

机构信息

From the Department of Medicine (P.P., I.M.B.), Department of Surgery (K.V., N.P.), Western University; Trauma Program (K.V., F.P., N.P., I.M.B.), London Health Sciences Centre; Office of Academic Military Medicine (N.P., I.M.B.), and Department of Epidemiology and Biostatistics (I.M.B.), Western University, London, Ontario, Canada.

出版信息

J Trauma Acute Care Surg. 2022 Oct 1;93(4):496-502. doi: 10.1097/TA.0000000000003562. Epub 2022 Feb 7.

DOI:10.1097/TA.0000000000003562
PMID:35137728
Abstract

BACKGROUND

Traumatic rib fractures (TRFs) are common with a 10% incidence in all trauma patients and are associated with significant morbidity and mortality. Adequate analgesia is paramount for preventing pulmonary complications and death. Evidence exists for intravenous (IV) lidocaine's effectiveness and safety in postoperative thoracic and abdominal surgery, and we hypothesized that it would be effective in patients with TRFs.

METHODS

We conducted a single-center, double-blind, randomized control trial comparing IV lidocaine plus usual analgesics to placebo infusion plus usual analgesics for 72 hours to 96 hours. Participants were adult trauma patients diagnosed with two or more TRFs requiring hospital admission. The primary outcome was mean pain score at rest and with movement, as measured on the visual analog scale. Secondary outcomes included patient satisfaction and opioid requirements (standardized total morphine equivalents). The study was powered to detect a 20% reduction in pain scores, which has been deemed clinically meaningful.

RESULTS

Thirty-six patients were enrolled and randomized to IV lidocaine or placebo. Comparison of the mean visual analog scale pain scores demonstrated significant pain reduction with movement in the lidocaine group compared with placebo (7.05 ± 1.72 vs. 8.22 ± 1.28, p = 0.042). Although pain scores at rest were reduced in the lidocaine group, this difference was not statistically significant (3.37 ± 2.00 vs. 3.82 ± 1.97; p = 0.519). Patient satisfaction was higher in the lidocaine group than the placebo group, although this did not reach statistical significance (8.3; interquartile range [IQR], 7.0-9.6 vs. 6.3; IQR, 5.2-7.1; p = 0.105). Total morphine equivalents were lower in the lidocaine group than the placebo group, but this difference did not reach statistical significance (167; IQR, 60-340 vs. 290; IQR 148-390; p = 0.194).

CONCLUSION

These results demonstrate that lidocaine has a beneficial analgesic effect in patients with TRFs. Future work is needed to evaluate lidocaine's ability to reduce patient important consequences of inadequate analgesia.

LEVEL OF EVIDENCE

Therapeutic/Care Management; Level II.

摘要

背景

创伤性肋骨骨折(TRF)在所有创伤患者中的发生率为 10%,与显著的发病率和死亡率相关。充分的镇痛对于预防肺部并发症和死亡至关重要。静脉(IV)利多卡因在胸腹部手术后的有效性和安全性已有证据,我们假设它对 TRF 患者有效。

方法

我们进行了一项单中心、双盲、随机对照试验,比较了 IV 利多卡因加常规镇痛剂与安慰剂输注加常规镇痛剂 72 至 96 小时的效果。参与者为成人创伤患者,诊断为需要住院治疗的两处或多处 TRF。主要结局是静息和运动时的平均疼痛评分,采用视觉模拟评分法(VAS)测量。次要结局包括患者满意度和阿片类药物需求(标准化总吗啡当量)。该研究的目的是检测疼痛评分降低 20%,这被认为具有临床意义。

结果

共纳入 36 例患者,并随机分为 IV 利多卡因组或安慰剂组。与安慰剂组相比,利多卡因组运动时的 VAS 疼痛评分显著降低(7.05 ± 1.72 对 8.22 ± 1.28,p = 0.042)。尽管利多卡因组静息时的疼痛评分有所降低,但差异无统计学意义(3.37 ± 2.00 对 3.82 ± 1.97;p = 0.519)。利多卡因组的患者满意度高于安慰剂组,但差异无统计学意义(8.3;四分位距[IQR],7.0-9.6 对 6.3;IQR,5.2-7.1;p = 0.105)。利多卡因组的吗啡当量总消耗量低于安慰剂组,但差异无统计学意义(167;IQR,60-340 对 290;IQR,148-390;p = 0.194)。

结论

这些结果表明,利多卡因对 TRF 患者具有有益的镇痛作用。需要进一步的研究来评估利多卡因减少镇痛不足患者重要后果的能力。

证据水平

治疗/护理管理;II 级。

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