Brown Luke, Weir Tristan, Koenig Scott, Shasti Mark, Yousaf Imran, Yousaf Omer, Tannous Oliver, Koh Eugene, Banagan Kelley, Gelb Daniel, Ludwig Steven
University of Maryland School of Medicine, Baltimore, MD, USA.
Global Spine J. 2019 Apr;9(2):133-137. doi: 10.1177/2192568218755684. Epub 2018 Jul 31.
Single-blinded prospective randomized control trial.
To compare the incidence of adverse events (AEs) and hospital length of stay between patients who received liposomal bupivacaine (LB) versus a single saline injection, following posterior lumbar decompression and fusion surgery for degenerative spondylosis.
From 2015 to 2016, 59 patients undergoing posterior lumbar decompression and fusion surgery were prospectively enrolled and randomized to receive either 60 mL injection of 266 mg LB or 60 mL of 0.9% sterile saline, intraoperatively. Outcome measures included the incidence of postoperative AEs and hospital length of stay.
The most common AEs in the treatment group were nausea (39.3%), emesis (18.1%), and hypotension (18.1%). Nausea (23%), constipation (19.2%), and urinary retention (15.3%) were most common in the control group. Patients who received LB had an increased risk of developing nausea (relative risk [RR] = 1.7; 95% confidence interval [CI] = 0.75-3.8), emesis (RR = 2.3; 95% CI = 0.51-10.7), and headaches (RR = 2.36; 95% CI = 0.26-21.4). Patients receiving LB had a decreased risk of developing constipation (RR = 0.78; 95% CI = 0.25-2.43), urinary retention (RR = 0.78; 95% CI = 0.21-2.85), and pruritus (RR = 0.78; 95% = 0.21-2.8) postoperatively. Relative risk values mentioned above failed to reach statistical significance. No significant difference in the hospital length of stay between both groups was found (3.9 vs 3.9 days; = .92).
Single-dose injections of LB to the surgical site prior to wound closure did not significantly increase or decrease the incidence or risk of developing AEs postoperatively. Furthermore, no significant difference was found in the hospital length of stay between both groups.
单盲前瞻性随机对照试验。
比较接受脂质体布比卡因（LB）与单次注射生理盐水的患者在退行性脊柱病后路腰椎减压融合手术后不良事件（AE）的发生率和住院时间。
2015年至2016年，前瞻性纳入59例行后路腰椎减压融合手术的患者，并随机分为术中接受60 mL注射266 mg LB或60 mL 0.9%无菌生理盐水两组。观察指标包括术后AE的发生率和住院时间。
治疗组最常见的AE为恶心（39.3%）、呕吐（18.1%）和低血压（18.1%）。对照组最常见的为恶心（23%）、便秘（19.2%）和尿潴留（15.3%）。接受LB的患者发生恶心（相对风险[RR]=1.7；95%置信区间[CI]=0.75 - 3.8）、呕吐（RR = 2.3；95% CI = 0.51 - 10.7）和头痛（RR = 2.36；95% CI = 0.26 - 21.4）的风险增加。接受LB的患者术后发生便秘（RR = 0.78；95% CI = 0.25 - 2.43）、尿潴留（RR = 0.78；95% CI = 0.21 - 2.85）和瘙痒（RR = 0.78；95% = 0.21 - 2.8）的风险降低。上述相对风险值未达到统计学意义。两组患者住院时间无显著差异（3.9天对3.9天；P = 0.92）。
伤口闭合前在手术部位单次注射LB并未显著增加或降低术后AE的发生率或风险。此外，两组患者住院时间无显著差异。
