Department of Anesthesia and Intensive Care, Hospital Santa Maria degli Angeli, Pordenone, Italy.
Curr Med Res Opin. 2012 Oct;28(10):1597-608. doi: 10.1185/03007995.2012.719864. Epub 2012 Sep 10.
Although numerous methods are available for postoperative pain (POP) management, new approaches are constantly being investigated. This feasibility study assessed the buprenorphine transdermal therapeutic system (Bup-TTS) for the treatment of POP after gynecological open surgery.
Forty-five patients were prospectively randomized to different Bup-TTS dosages (17.5, 35, or 52.5 μg/h). Patients were blinded with regard to patch dose.
Efficacy was evaluated in terms of rescue boluses (intravenous morphine 2 mg in the first six postoperative hours, intravenous ketorolac 30 mg thereafter) required to achieve a static and dynamic Numerical Rating Scale (sNRS and dNRS) score ≤4. Side effects were evaluated from patch application (12 hours before surgery) until the 72nd postoperative hour. Patient satisfaction regarding POP management was assessed via anonymous questionnaire.
All Bup-TTS groups required additional postoperative analgesia, particularly in the first postoperative hour. No between-group differences in sNRS/dNRS values were recorded at emergence from anesthesia. A significant inverse correlation occurred between Bup-TTS dosage and use of morphine (p = 0.04), ketorolac (p = 0.04) or both rescues (p = 0.02). Postoperative nausea/vomiting occurred in 3.1% of assessments, with no between-group differences and a significant correlation with morphine amount (p = 0.01). No serious side effects occurred. Despite no between-group difference, patient satisfaction was inversely correlated with the number of rescue doses (p < 0.001). Study limitations include the small sample size, the absence of a control group treated with a more conventional technique for POP relief, the focus on selected patients at low perioperative risk and the presence of slightly different types of open surgery (hysterectomy vs myomectomy only).
Bup-TTS efficacy was directly proportional to its dosage, although additional analgesia was required, particularly in the first postoperative hour. Moreover, the consumption of morphine and ketorolac was inversely correlated to the Bup-TTS dosage. Increasing Bup-TTS doses were not associated with an increased incidence of side effects. Bup-TTS appears a safe and feasible approach for moderate POP management; further larger studies are warranted.
尽管有许多方法可用于术后疼痛（POP）管理，但仍在不断研究新方法。本可行性研究评估了丁丙诺啡透皮治疗贴（Bup-TTS）在妇科开放性手术后 POP 治疗中的应用。
45 例患者前瞻性随机分为不同 Bup-TTS 剂量（17.5、35 或 52.5μg/h）。患者对贴剂剂量不知情。
根据静息和动态数字评分量表（sNRS 和 dNRS）评分≤4 分所需的解救剂量（术后前 6 小时静脉注射吗啡 2mg，之后静脉注射酮咯酸 30mg）来评估疗效。从贴剂应用（手术前 12 小时）到术后第 72 小时评估不良反应。通过匿名问卷评估患者对 POP 管理的满意度。
所有 Bup-TTS 组均需要额外的术后镇痛，特别是在术后第 1 小时。麻醉苏醒时，各组间 sNRS/dNRS 值无差异。Bup-TTS 剂量与吗啡（p=0.04）、酮咯酸（p=0.04）或两者解救用量呈显著负相关（p=0.02）。术后恶心/呕吐发生率为 3.1%，组间无差异，与吗啡用量显著相关（p=0.01）。无严重不良反应。尽管组间无差异，但患者满意度与解救剂量的数量呈负相关（p<0.001）。研究局限性包括样本量小、缺乏 POP 缓解的更常规技术对照治疗组、关注低围手术期风险的特定患者以及存在略有不同类型的开放性手术（子宫切除术与子宫肌瘤切除术）。
Bup-TTS 的疗效与其剂量成正比，但仍需要额外的镇痛，特别是在术后第 1 小时。此外，吗啡和酮咯酸的用量与 Bup-TTS 剂量呈负相关。增加 Bup-TTS 剂量不会增加不良反应的发生率。Bup-TTS 似乎是一种安全可行的中度 POP 管理方法；需要进一步的更大规模研究。
