Hartjen K, Fischer M V, Mewes R, Paravicini D
Anaesthesiologische Klinik, Städtisches Krankenhaus Gütersloh.
Anaesthesist. 1996 Jun;45(6):538-44. doi: 10.1007/s001010050288.
Even today, adequate postoperative analgesia is still a great problem. Based on positive results of former studies using a continuous infusion of tramadol for postoperative pain relief, we aimed to improve this regimen. In order to investigate the effectiveness of preventive analgesia, one group of patients was given 100 mg tramadol (Tramal) at the time of extubation, followed by a maintenance infusion. The other group was treated with single boluses of tramadol on demand, thus representing common pain treatment. METHODS. 112 patients undergoing abdominal surgery were chosen at random for this double-blind study. Half of them (preventive group) received an injection of 100 mg tramadol at the time of extubation; the others (on-demand group) were given a placebo instead. A continuous infusion of 500 ml NaCl 0.9% (administered with 30 ml/h) followed, either containing 200 mg tramadol (preventive group) or a placebo (on-demand group) and was maintained until the end of the study. At the first expression of pain, patients in the preventive group received 50 mg tramadol (representing the first subsequent injection) whereas patients of the on-demand group were given 100 mg tramadol as a loading dose. For further treatment of pain, the members of both groups received 50 mg tramadol when necessary. The level of pain was assessed by means of VAS (visual analogue scale) every hour and additionally at first expression of pain, and finally by VRS (verbal rating scale) after eight hours at the end of the study. RESULTS. 112 patients were chosen at random. 18 had to be excluded--two treatment failures, twelve violations of the study protocol and four patients of the on-demand group, who did not ask for treatment for pain and therefore did not receive any tramadol. Hence only 94 patients could be statistically evaluated. 50% of the remaining 48 patients in the preventive group needed none or only one subsequent injection of tramadol, the other 50% needed two or more subsequent injections. However the patients in the on-demand group, now 46, split up into 71.7% who where administered up to one subsequent injection and 28.3% who received more than one subsequent injection. The number of patients who asked for treatment for pain twice or more during the study period totalled 50% in the preventive group and 58.7% in the on-demand group. The average interval between extubation and first expression of pain was 106.3 +/- 84.2 min in the preventive group, and 75.0 +/- 22.7 min in the on-demand group. The intensity of pain evaluated by VAS as that time was comparable: 55.6 +/- 22.7 (preventive) versus (63.4 +/- 18.3 (on demand). The pain relief obtained, shown by the VAS-differences between the first expression of pain and following assessment, came up to 27.7 +/- 22.9 in the preventive group and 30.3 +/- 23.4 in the on-demand group within a period of 46.2 +/- 17.2 min (preventive) and 43.7 +/- 17.2 min (on-demand). Retrograde assessment of pain (VRS) showed that 85.5% of the preventive group found pain relief excellent or good and 78.3% of the on-demand group were of the same opinion. Total consumption of tramadol totalled 281.4 +/- 53.6 mg in the preventive group in comparison with 150.0 +/- 53.7 mg in the on-demand group. CONCLUSIONS. Only 28.3% of patients of the on-demand group received more than one subsequent injection of tramadol in comparison with 50% of the preventive group--an unexpected result. However, it has to be considered that the injection of tramadol given at the first expression of pain in the preventive group was counted as the first subsequent injection already. The patients in the preventive group asked, on average, 30 min later for treatment for pain. The subsequent pain relief in both groups was comparable, although the amount of tramadol administered at that time was higher in the on demand group than in the preventive group (100 mg versus 50 mg+ amount given by infusion). These facts show the efficacy of the preventive infus
即使在今天，充分的术后镇痛仍然是一个大问题。基于以往使用曲马多持续输注进行术后镇痛的研究取得的积极成果，我们旨在改进这一方案。为了研究预防性镇痛的效果，一组患者在拔管时给予100毫克曲马多（曲马朵），随后进行维持输注。另一组患者根据需要给予曲马多单次推注，从而代表常规疼痛治疗。方法。112例接受腹部手术的患者被随机选入这项双盲研究。其中一半（预防组）在拔管时接受100毫克曲马多注射；其余患者（按需组）则给予安慰剂。随后进行500毫升0.9%氯化钠的持续输注（以30毫升/小时的速度给药），其中一组含有200毫克曲马多（预防组），另一组含有安慰剂（按需组），并持续至研究结束。在首次出现疼痛时，预防组患者接受50毫克曲马多（代表首次后续注射），而按需组患者则给予100毫克曲马多作为负荷剂量。为了进一步治疗疼痛，两组患者在必要时均接受50毫克曲马多。每小时通过视觉模拟量表（VAS）评估疼痛程度，在首次出现疼痛时额外评估一次，最后在研究结束8小时后通过语言评定量表（VRS）评估。结果。随机选取112例患者。18例必须被排除——2例治疗失败，12例违反研究方案，4例按需组患者未要求疼痛治疗，因此未接受任何曲马多。因此，只有94例患者能够进行统计学评估。预防组其余48例患者中有50%不需要或只需要一次后续曲马多注射，另外50%需要两次或更多次后续注射。然而，按需组的46例患者中，71.7%接受了至多一次后续注射，28.3%接受了不止一次后续注射。在研究期间要求两次或更多次疼痛治疗的患者数量在预防组中占50%，在按需组中占58.7%。预防组拔管至首次出现疼痛的平均间隔时间为106.3±84.2分钟，按需组为75.0±22.7分钟。此时通过VAS评估的疼痛强度相当：55.6±22.7（预防组）对63.4±18.3（按需组）。在46.2±17.2分钟（预防组）和43.7±17.2分钟（按需组）内，通过首次出现疼痛与后续评估之间的VAS差异显示的疼痛缓解程度，预防组为27.7±22.9，按需组为3 .3±23.4。疼痛的逆向评估（VRS）显示，预防组85.5%的患者认为疼痛缓解优秀或良好，按需组78.3%的患者持相同看法。预防组曲马多的总消耗量为281.4±53.6毫克，而按需组为150.0±53.7毫克。结论。按需组只有（此处原文有误，根据前文应是28.3%）的患者接受了不止一次后续曲马多注射，而预防组为50%——这是一个意想不到的结果。然而，必须考虑到预防组在首次出现疼痛时给予的曲马多注射已被计为首次后续注射。预防组患者平均在30分钟后要求疼痛治疗。两组后续的疼痛缓解程度相当，尽管此时按需组给予的曲马多量高于预防组（100毫克对50毫克+输注给予的量）。这些事实表明了预防性输注的疗效
