预防性镇痛在胃癌根治术中应用价值的前瞻性研究

Clinical value of preventive analgesia in patients with radical gastrectomy for gastric cancer： a prospective study

目的探讨预防性镇痛方案在胃癌患者行胃癌根治术中的应用价值。方法选取2012年7月至2013年6月第四军医大学西京消化病医院行胃癌根治术的161例患者行前瞻性随机研究。采用随机、单盲对照法，通过随机数字表法将入组患者分为预防性镇痛组和对照组。两组患者行胃癌根治术，包括传统胃大部分切除联合毕Ⅱ式吻合术，或全胃切除联合食管空肠吻合术，术后均经空肠营养管给予肠内营养。预防性镇痛组开腹前给予地塞米松10mg和帕瑞昔布200mg静脉注射，开腹前、入腹后、关腹时在腹壁切口周围浸润注射0．5％罗哌卡因7-8mL，术后连续3d口服塞来昔布。对照组仅在术后给予静脉留置管泵注入镇痛剂。记录2组患者视觉模拟评分（VAS）、术后每天下床活动时间〉8h的患者例数、术后肛门排气时间、术后排便时间、住院时间。正态分布的计量资料采用哥±s表示，组间比较采用t检验和重复测量方差分析；偏态分布数据和等级资料采用秩和检验；计数资料采用四格表，检验。结果筛选出符合研究条件的患者161例，分为预防性镇痛组（87例）和对照组（74例）。预防性镇痛组患者术后第1、2、3天VAS评分分别为（2．8±0．6）分、（2．6±0．4）分、（1．8±0．4）分，对照组患者分别为（5．3±0．5）分、（4．2±0．6）分、（2．4±0．3）分，两组比较，差异有统计学意义（F=4．25，P〈0．05）。预防性镇痛组患者术后第1、2、3天每天下床活动时间〉8h的例数分别为8、17、20例，对照组分别为0、3、11例，两组比较，差异有统计学意义（X^2=7．60，10．26，3．16，P〈0．05）。预防性镇痛组患者术后肛门排气时间、术后排便时间和术后住院时间分别为（51±24）h、（61±24）h、（5．5±3．0）d，对照组分别为（71±23）h、（83±30）h、（6．3±2．1）d，两组比较，差异有统计学意义（t=5．32，5．04，0．17，P〈0．05）。两组患者术后均顺利康复，未出现呼吸抑制和切口感染等并发症及药物不良反应。结论胃癌患者施行胃癌根治术围术期采用预防性镇痛方案，可减轻患者术后疼痛，促进患者肠道功能恢复，加速患者术后康复。临床试验注册在中国临床试验注册中心注册，注册号为ChiCTR-TRC-11001440。

Objective To investigate the clinical value of preventive analgesia iN patients with radical gastrectomy for gastric cancer. Methods The clinical data of 161 patients undergoing radical gastrectomy for gastric cancer at the Xijing Hospital from July 2012 to June 2013 were prospectively analyzed. A single-blind, randomized, controlled study was performed in the eligibe patients who were randomly divided into the preventive analgesia group and the control group based on a random number table. All the patients received major gastrectomy ＋ Billroth II anastomy or total gastrectomy ＋ esophagojejunastomy, and then they received vein combined anesthesia and tracheal intubation. In the preventive analgesia group, 10 mg dexamethasone and 200 mg parecoxib were administered by intravenous infusion before operation, 7-8 mL ropivaeaine （0.5 % ） were injected at the incisional site and transversus abdominis infiltration at open and close surgery and celecoxib was taken orally for 3 days. In the control group, vein analgesia pump was used after operation. The visual analogue scale （VAS）, proportion of patients with postoperative out-off-bed activity time 〉 8 hours, time of flatus, time of defecation and duration of hospital stay were recorded between the 2 groups. The measurement data with normal distribution were presented as x-± s. The comparison between groups was evaluated with the t test and repeated measures ANOVA. The data with skew distrubution and ordinal data were analyzed by the analysis of variance, and the count data were analyzed using the chi-square test. Results All the 161 patients who were screened for eligibility were randomly divided into the preventive analgesia group （87 patients） and the control group （74 patients）. The scores of the VAS atpostoperative day 1, 2 and 3 were 2.8± 0.6, 2.6±0.4 and 1.8±0.4 in the preventive analgesia group, and 5.3±0.5, 4.2±0.6 and 2.4±0.3 in the control group, with a significant difference between the 2 groups （ F = 4. 25, P 〈 0.05 ）. The proportion of patients with postoperative first abmulation time 〉 8 hours at postoperative day l, 2 and 3 were 8, 17 and 20 in the preventive analgesia group, and 0, 3 and 11 in the control group, with a sig- nificant difference between the 2 groups （X^2 = 7.60, 10.26, 3.16, P 〈 0.05 ）. The time of flatus , time of defeca- tion and duration of hospital stay were （ 51±24 ） hours, （ 61 ± 24 ） hours and （ 5.5±3.0 ） days in the preventive analgesia group, compared with （71±23 ）hours, （83±30）hours and （6.3±2.1 ）days in the control group, show- ing a significant difference between the 2 groups （t = 5.32, 5.04, 0. 17, P 〈 0.05 ）. All the patients in the 2 groups normally survived after surgery without respiratory depression, incision infection and adverse drug reaction. Conclusions Preventive analgesia in the perioperative treatment of patients with radical gastrectomy for gastric cancer could relieve the postoperative pain of patients, improve the bowel function and enhance the recovery of patients. Registry This study was registered with the Chinese Clinical Trial Registry with the registry number of ChiCTR- TRC- 11001440.