Abstract：
A temperature-responsive hydrogel (PF-72; TGel Bio, Inc., Ltd, Seoul, Korea), developed as a sustained drug delivery device, can be mixed with ropivacaine to reduce pain in the incision area. The hydrogel is soluble at low temperatures (2-8 °C) and is converted into a gel at high temperatures (> 30 °C). We aimed to evaluate whether the administration of ropivacaine using PF-72 at incision sites reduces pain until 72 h postoperatively in patients undergoing laparoscopic stomach or colorectal surgery.
Patients were randomly assigned to the control group (0.75% ropivacaine) or PF-72 group (PF-72 mixed with 0.75% ropivacaine). Before surgical incision closure, 0.75% ropivacaine or PF-72 mixed with 0.75% ropivacaine was injected into the subcutaneous fat and muscle of all incisions. Postoperative pain was evaluated by the Numerical Rating Scale (NRS, 0 = no pain, 10 = most severe pain) for wound pain at 3, 6, 24, 48, and 72 h after the end of surgery.
Ninety-nine patients (control, n = 51; PF-72, n = 48) were included in the analysis. The areas under the curve of NRS for wound pain until 72 h in the control group and the PF-72 group were 188.7 ± 46.1 and 135.3 ± 49.9 h, respectively (P < 0.001). The frequency of the administration of rescue analgesics in the general ward was similar between the two groups.
PF-72 mixed with 0.75% ropivacaine reduced postoperative pain until 72 h in patients undergoing laparoscopic surgery. Although the study population was not large enough for safety evaluation, no adverse events associated with PF-72 were observed.
Patients were randomly assigned to the control group (0.75% ropivacaine) or PF-72 group (PF-72 mixed with 0.75% ropivacaine). Before surgical incision closure, 0.75% ropivacaine or PF-72 mixed with 0.75% ropivacaine was injected into the subcutaneous fat and muscle of all incisions. Postoperative pain was evaluated by the Numerical Rating Scale (NRS, 0 = no pain, 10 = most severe pain) for wound pain at 3, 6, 24, 48, and 72 h after the end of surgery.
Ninety-nine patients (control, n = 51; PF-72, n = 48) were included in the analysis. The areas under the curve of NRS for wound pain until 72 h in the control group and the PF-72 group were 188.7 ± 46.1 and 135.3 ± 49.9 h, respectively (P < 0.001). The frequency of the administration of rescue analgesics in the general ward was similar between the two groups.
PF-72 mixed with 0.75% ropivacaine reduced postoperative pain until 72 h in patients undergoing laparoscopic surgery. Although the study population was not large enough for safety evaluation, no adverse events associated with PF-72 were observed.
摘要：
一种温度响应性水凝胶(PF-72；TGelBio，Inc.,Ltd,首尔,Korea),作为一种持续的药物输送装置，可以与罗哌卡因混合以减轻切口区域的疼痛。水凝胶在低温(2-8°C)下是可溶的,并且在高温(>30°C)下转化为凝胶。我们旨在评估在接受腹腔镜胃或结直肠手术的患者中，在切口部位使用PF-72的罗哌卡因是否可以减轻疼痛，直到术后72小时。
患者随机分为对照组（0.75％罗哌卡因）或PF-72组（PF-72与0.75％罗哌卡因混合）。手术切口闭合前，将0.75％罗哌卡因或与0.75％罗哌卡因混合的PF-72注射到所有切口的皮下脂肪和肌肉中。术后疼痛通过数值评定量表(NRS，0=没有疼痛，10=最严重的疼痛），用于手术结束后3、6、24、48和72h的伤口疼痛。
九十九名患者(对照，n=51；PF-72，n=48）包括在分析中。对照组和PF-72组直到72h的伤口疼痛NRS曲线下面积分别为188.7±46.1和135.3±49.9h，分别(P<0.001)。两组在普通病房中使用抢救镇痛药的频率相似。
在接受腹腔镜手术的患者中，PF-72与0.75％罗哌卡因混合可减轻术后疼痛直至72h。尽管研究人群不足以进行安全性评估，未观察到与PF-72相关的不良事件.
患者随机分为对照组（0.75％罗哌卡因）或PF-72组（PF-72与0.75％罗哌卡因混合）。手术切口闭合前，将0.75％罗哌卡因或与0.75％罗哌卡因混合的PF-72注射到所有切口的皮下脂肪和肌肉中。术后疼痛通过数值评定量表(NRS，0=没有疼痛，10=最严重的疼痛），用于手术结束后3、6、24、48和72h的伤口疼痛。
九十九名患者(对照，n=51；PF-72，n=48）包括在分析中。对照组和PF-72组直到72h的伤口疼痛NRS曲线下面积分别为188.7±46.1和135.3±49.9h，分别(P<0.001)。两组在普通病房中使用抢救镇痛药的频率相似。
在接受腹腔镜手术的患者中，PF-72与0.75％罗哌卡因混合可减轻术后疼痛直至72h。尽管研究人群不足以进行安全性评估，未观察到与PF-72相关的不良事件.
