脂质体布比卡因用于全膝关节置换术后镇痛的股神经阻滞

Liposome Bupivacaine Femoral Nerve Block for Postsurgical Analgesia after Total Knee Arthroplasty.

作者信息

Hadzic Admir, Minkowitz Harold S, Melson Timothy I, Berkowitz Richard, Uskova Anna, Ringold Forrest, Lookabaugh Janice, Ilfeld Brian M

机构信息

From the Departments of Anesthesiology, St. Luke's and Roosevelt Hospitals, New York, New York, and Ziekenhouse Oost Limburgh, Genk, Belgium, and the New York School of Regional Anesthesia (NYSORA), New York, New York (A.H.); Department of Anesthesiology, Memorial Hermann Memorial City Medical Center, Houston, Texas (H.S.M.); Department of Anesthesiology, Sheffield Anesthesia, Helen Keller Memorial Hospital, Sheffield, Alabama (T.I.M.); Department of Joint Replacement Surgery, University Hospital, Tamarac, Florida (R.B.); Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (A.U.); Veritas Research, LLC, Mobile, Alabama (F.R.); Pacira Pharmaceuticals, Inc., Parsippany, New Jersey (J.L.); and Department of Anesthesiology, University of California, San Diego, San Diego, California (B.M.I.).

出版信息

Anesthesiology. 2016 Jun;124(6):1372-83. doi: 10.1097/ALN.0000000000001117.

DOI:10.1097/ALN.0000000000001117

PMID:27035853

Abstract

BACKGROUND

The authors evaluated the efficacy of liposome bupivacaine in a femoral nerve block (FNB) after total knee arthroplasty.

METHODS

Part 1: subjects received FNB with 20 ml liposome bupivacaine (67, 133, or 266 mg) or placebo. Part 2: subjects were randomized to FNB with liposome bupivacaine 266 mg or placebo. The primary outcome measure was area under the curve of the numeric rating scale score for pain intensity at rest through 72 h (AUC NRS-R0-72) with imputed scores after rescue medication.

RESULTS

In part 1, FNB with liposome bupivacaine 266 mg (n = 24) resulted in analgesia similar to that obtained with 133 mg and was chosen for part 2. In part 2, least-squares mean (standard error) AUC NRS-R0-72 was lower with liposome bupivacaine 266 mg (n = 92) than with placebo (n = 91; 419 [17] vs. 516 [17]; P < 0.0001). This outcome remained unchanged in a post hoc analysis without score imputation (221 [12] vs. 282 [12]; P = 0.0005). Least-squares mean AUC NRS-R with imputed scores was lower with liposome bupivacaine during each 24-h interval (0 to 24, 24 to 48, and 48 to 72 h) after surgery; AUC NRS-R without imputed scores was lower during the 0- to 24-h and 24- to 48-h intervals. The liposome bupivacaine group had lower mean total opioid use (76 vs. 103 mg morphine; P = 0.0016). Pain was sufficiently severe to require second-step rescue with opioids via intravenously administered patient-controlled analgesia in 92% of liposome bupivacaine patients and 81% of placebo patients. With patient-controlled analgesia and other forms of rescue analgesia, mean NRS scores with activity were moderate in both liposome bupivacaine and placebo groups throughout the part 2 study period. Incidence of adverse events was similar between the groups (part 1: 90 vs. 96%; part 2: 96 vs. 96%, respectively).

CONCLUSION

FNB with liposome bupivacaine (266 mg) resulted in modestly lower pain scores and reduced opioid requirements after surgery, with an adverse event profile similar to placebo.

摘要

背景

作者评估了脂质体布比卡因在全膝关节置换术后股神经阻滞（FNB）中的疗效。

方法

第1部分：受试者接受20毫升脂质体布比卡因（67、133或266毫克）或安慰剂的FNB。第2部分：受试者被随机分为接受266毫克脂质体布比卡因或安慰剂的FNB。主要结局指标是静息时疼痛强度数字评分量表评分至72小时的曲线下面积（AUC NRS-R0-72），并在使用解救药物后进行分数估算。

结果

在第1部分中，266毫克脂质体布比卡因（n = 24）的FNB产生的镇痛效果与133毫克时相似，因此被选用于第2部分。在第2部分中，266毫克脂质体布比卡因组（n = 92）的最小二乘均值（标准误）AUC NRS-R0-72低于安慰剂组（n = 91；419 [17]对516 [17]；P < 0.0001）。在不进行分数估算的事后分析中，这一结果保持不变（221 [12]对282 [12]；P = 0.0005）。在术后每个24小时间隔（0至24、24至48和48至72小时），脂质体布比卡因组估算分数后的最小二乘均值AUC NRS-R较低；未估算分数的AUC NRS-R在0至24小时和24至48小时间隔较低。脂质体布比卡因组的平均总阿片类药物使用量较低（76毫克吗啡对103毫克；P = 0.0016）。92%的脂质体布比卡因组患者和81%的安慰剂组患者疼痛严重到需要通过静脉自控镇痛进行第二步阿片类药物解救。在第2部分研究期间，在自控镇痛和其他形式的解救镇痛情况下，脂质体布比卡因组和安慰剂组活动时的平均NRS评分均为中度。两组间不良事件发生率相似（第1部分：分别为90%对96%；第2部分：分别为96%对96%）。