Lehmann L J, DeSio J M, Radvany T, Bikhazi G B
Department of Anesthesiology, Harvard University, Beth Israel Hospital, Boston, Massachusetts, USA.
Reg Anesth. 1997 Jan-Feb;22(1):24-8. doi: 10.1016/s1098-7339(06)80052-0.
The aim of this study was to determine the safety and effectiveness of a transdermal fentanyl delivery system for the relief of pain following abdominal surgery.
In a nonblinded, noncrossover, placebo-controlled study, 40 ASA I and II patients of both sexes, 18-69 years of age, who were scheduled for abdominal surgery under general anesthesia, were randomly divided into two groups of 20 patients each. Patients in group I received a transdermal patch containing 0.16 mg/cm2 of fentanyl, which was applied to the skin over the subclavian area 60 minutes before the induction of anesthesia. For body weight less than 60 kg, a 30 cm2 patch was applied, and for weight greater than 60 kg, a 40 cm2 patch was used. A second group of 20 patients received placebo patches of identical size. Approximately 20 to 30 minutes before the expected end of surgery, 60 mg ketorolac was administered intramuscularly. Patients were observed for 36 hours after placement of the patch. If patients reported their pain at rest as 5 or greater at rest on a 0-10 visual analog scale, they were given 30-mg increments of ketorolac 5 to 7 hours apart. If this regimen did not relieve their pain, they received 1,300 mg acetaminophen between two ketorolac doses. If despite this, they still had pain 30 minutes afterward, intravenous morphine was given, and the patients were excluded from further study. The patch was removed in four patients in the fentanyl group and seven in the placebo group for various reasons, which included, inadequate pain relief requiring additional analgesia postoperatively and more than 1 microgram/kg of sufentanil given intraoperatively or immediately prior to the end of surgery. During the 36-hour observation period, 30 doses of 30 mg ketorolac and 14 doses of 1.3 g acetaminophen were given to 13 patients in the placebo group and 18 doses of ketorolac and 8 doses of acetaminophen were administered to 16 in the fentanyl group.
The differences in postoperative analgesic requirements were significant. Plasma fentanyl concentrations at 12 and 24 hours after the application of the fentanyl patch were 0.98 +/- 0.14 ng/mL and 1.22 +/- 0.17 ng/mL, respectively. At 8, 16, 24, and 36 hours after application of the patch, the pain relief, assessed by a VAS at rest and with movement, was similar in the two groups. In the fentanyl and control groups, 12 and 5 patients, respectively, experienced nausea, and 2 and 3 patients, respectively, vomited.
Similar postoperative analgesia was achieved with less parenteral analgesics in patients who received transdermal fentanyl preoperatively than in control patients. Fentanyl, 50-75 micrograms/h, administered in a transdermal delivery system, did not depress respiratory rate or hemoglobin oxygen saturation. Although the exact role of continuously administered opioids in managing acute postoperative pain has yet to be clearly defined, it is concluded that if properly used, this new transdermal device can be effective in providing a background of analgesia, which may assist in the management of acute postoperative pain as well as some chronic pain states.
本研究旨在确定经皮芬太尼给药系统缓解腹部手术后疼痛的安全性和有效性。
在一项非盲、非交叉、安慰剂对照研究中，40例年龄在18 - 69岁、拟行全身麻醉下腹部手术的ASA I级和II级男女患者被随机分为两组，每组20例。第一组患者在麻醉诱导前60分钟接受一片含0.16 mg/cm²芬太尼的透皮贴剂，贴于锁骨下区域皮肤。体重小于60 kg者贴30 cm²的贴剂，体重大于60 kg者贴40 cm²的贴剂。第二组20例患者接受相同尺寸的安慰剂贴剂。在预计手术结束前约20至30分钟肌肉注射60 mg酮咯酸。贴剂贴上后对患者观察36小时。如果患者在0 - 10视觉模拟量表上报告静息时疼痛为5或更高，则每隔5至7小时给予30 mg递增剂量的酮咯酸。如果该方案不能缓解疼痛，则在两次酮咯酸剂量之间给予1300 mg对乙酰氨基酚。即便如此，如果30分钟后仍有疼痛，则给予静脉注射吗啡，这些患者被排除在进一步研究之外。芬太尼组有4例患者、安慰剂组有7例患者因各种原因取下贴剂，原因包括术后疼痛缓解不足需要额外镇痛以及术中或手术结束前即刻给予超过1 μg/kg的舒芬太尼。在36小时观察期内，安慰剂组13例患者给予30 mg酮咯酸30次剂量和1.3 g对乙酰氨基酚14次剂量，芬太尼组16例患者给予酮咯酸18次剂量和对乙酰氨基酚8次剂量。
术后镇痛需求差异显著。芬太尼贴剂应用后12小时和24小时的血浆芬太尼浓度分别为0.98±0.14 ng/mL和1.22±0.17 ng/mL。贴剂应用后8、16、24和36小时，通过静息和活动时的视觉模拟量表评估的疼痛缓解情况在两组中相似。芬太尼组和对照组分别有12例和5例患者出现恶心，分别有2例和3例患者呕吐。
与对照组患者相比，术前接受经皮芬太尼的患者使用较少的胃肠外镇痛药即可获得相似效果的术后镇痛。以50 - 75 μg/h的速度经皮给药的芬太尼不会降低呼吸频率或血红蛋白氧饱和度。尽管持续给予阿片类药物在管理急性术后疼痛的确切作用尚未明确界定，但可以得出结论，如果正确使用，这种新型透皮装置可有效提供镇痛背景，这可能有助于管理急性术后疼痛以及一些慢性疼痛状态。
