Martin Gavin, Hartmannsgruber Maximilian, Riley Edward, Manvelian Garen
Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA.
J Opioid Manag. 2006 Jul-Aug;2(4):209-18. doi: 10.5055/jom.2006.0033.
This randomized, double-blind study compared the safety and efficacy of a new single-dose extended-release epidural morphine (EREM) formulation for postoperative pain following hip arthroplasty. Patients were administered a single dose of EREM (10, 20, or 30 mg, n = 93) or a single epidural dose of placebo (n = 27) before surgery and general anesthesia. Following surgery, patients had access to fentanyl with the use of intravenous patient-controlled analgesia. Postoperative fentanyl use, time to first postoperative fentanyl use, pain intensity at rest and with activity, patient ratings of pain control, and adverse events were recorded. Compared with placebo-treated patients, single-dose EREM patients used less total supplemental fentanyl (p < or = 0.049), had a longer time to first fentanyl use (p < 0.001), and were less likely to use any supplemental fentanyl (p < or = 0.042). EREM-treated patients reported lower pain intensity for up to 48 hours postdose compared with placebo-treated patients. Single-dose EREM was effective for postoperative pain relief for up to 48 hours following hip arthroplasty, with a safety and tolerability profile consistent with that of other epidurally administered opioids.
这项随机、双盲研究比较了一种新型单剂量缓释硬膜外吗啡（EREM）制剂用于髋关节置换术后疼痛的安全性和有效性。在手术和全身麻醉前，给患者单次注射EREM（10毫克、20毫克或30毫克，n = 93）或单次硬膜外注射安慰剂（n = 27）。术后，患者可使用芬太尼进行静脉自控镇痛。记录术后芬太尼的使用情况、首次使用芬太尼的时间、静息和活动时的疼痛强度、患者对疼痛控制的评分以及不良事件。与接受安慰剂治疗的患者相比，单剂量EREM患者使用的总补充芬太尼较少（p≤0.049），首次使用芬太尼的时间更长（p < 0.001），且使用任何补充芬太尼的可能性较小（p≤0.042）。与接受安慰剂治疗的患者相比，EREM治疗的患者在给药后长达48小时内报告的疼痛强度较低。单剂量EREM在髋关节置换术后长达48小时内对术后疼痛缓解有效，其安全性和耐受性与其他硬膜外给予的阿片类药物一致。
