两种镇痛方式对全膝关节置换术后疼痛及关节功能影响的随机对照研究

Effects of two analgesic regimens on the postoperative analgesia and knee functional recovery after unilateral total knee arthroplasty—a randomized controlled trial

目的 探讨连续股神经阻滞对全膝关节置换术（TKA）后镇痛效果及关节功能的影响.方法 前瞻性收集2011年1月至2013年12月符合纳入和排除标准的患者资料,共有280例患者入组,年龄40～ 75岁,ASA分级Ⅰ～Ⅲ级.采用随机数字表法将280例患者随机分为连续股神经阻滞（CFNB）组（n=140）和静脉自控镇痛（PCIA）组（n=140）.分别观察两组患者术后24、48、72 h、出院时、术后3、6、12个月运动及静息状态下的数字评价量表（NRS）评分,记录术后3、6、12个月中重度疼痛的发生情况及患者关节弯曲度和WOMAC评分,并记录补救药物使用情况及镇痛相关的不良事件.正态分布数据组间比较采用t检验;非正态分布资料组间比较采用Wilcoxon检验;计数资料采用χ^2检验,不符合χ^2检验要求的数据采用Fisher确切检验法.结果 CFNB组患者出院时、术后3、6个月运动NRS评分为3、3、3分,PCIA组患者为4、3、3分.CFNB组出院时、术后3、6个月静息NRS评分为3、1、1分,PCIA组为3、2、2分.CFNB组患者出院时（Z=-5.174,P＜0.05）、术后3个月（Z =2.308,P=0.021）、6个月（Z=-2.495,P=0.013）运动NRS评分及静息NRS评分（Z=-2.405,P=0.016;Z=-4.360,P＜0.05;Z=-9.268,P＜0.05）均低于PCIA组.CFNB组患者术后3、6个月关节活动度为92°、103°,PCIA组患者为89°、100°;CFNB组术后3、6个月WOMAC评分为21、18分,PCIA组为24、21分,术后3个月（Z=-2.175,P=0.030）、6个月（Z=-2.471,P=0.013）CFNB组关节活动度大于PCIA组,而WOMAC评分低于PCIA组（Z=-2.467,P=0.014;Z=-2.537,P=0.011）.CFNB组镇痛泵人均按压次数和补救用药次数分别为2.3和0.6次,PCIA组为2.6和1.1次,CFNB组镇痛泵人均按压次数（t=-2.984,P=0.003）及补救药物用药次数（t=-3.213,P=0.002）低于PCIA组.两组下肢肌力减退、恶心呕吐等不良事件发生率的差异均无统计学意义（P＞0.05）.结论 CFNB可减轻TKA术后疼痛且不良反应少,能够有效地提高TKA术后早、中期膝关节活动度,提高患者生活质量.

Objective To evaluate the efficacy of continuous femoral block on the postoperative analgesia and functional recovery after total knee arthroplasty（TKA）.Methods Two hundreds and eighty patients who underwent TKA were randomized into two groups：the group receiving continuous femoral block （CFNB） and the group receiving patient controlled intravenous analgesia （PCIA）,each group included 140 participants.Femoral nerve block with ropivacaine by ultrasonic guidance was performed in group CFNB and group PCIA were administrated with patient controlled intravenous analgesia.Numerical rating scale （NRS） scores at rest and in motion at 24,48,72 h,3,6 and 12 months postoperatively,also the N RS scores at hospital discharge were recorded.The incidence of moderate-severity pain,as well as the degree of knee flexion and the WOMAC scores at 3,6 and 12 months after surgery were analyzed.The rescue analgesic administration and analgesia-related adverse effects were also recorded.Data were expressed as mean ± standard deviation（SD） for normally distributed continuous variables and total number （percent frequency） for categorical variables.If non-normally distributed,data were expressed median inter-quartile range.Student＇s t-test,Wilcoxon rank test were used to compare results for continuous variables,when appropriate.Chi-square test was used to compare results for categorical variable,Fisher exact test was used for categorical variables when the number of event was less than 5.Results NRS scores of group CFNB in motion was 3（3-4） at discharge time,and 3（2-4）,3（2-3） at 3 months and 6 months postoperatively,while the scores of group PCIA was 4 （4-4）,3 （3-4）,3 （3-4）,respectively.And at rest,NRS scores of group CFNB was 3 （2-3）,1 （1-2）,1 （1-1） at discharge time,and 3,6 months postoperatively.Compared with group PCIA,NRS scores in motion of group CFNB at discharge time （Z =-5.174,P 〈 0.05） and 3 months（Z =2.308,P =0.021）,as well as 6 months postoperatively （Z =-2.495,P =0.013）,were significantly lower,also for the NRS scores at rest（Z =-2.405,P =0.016;Z =-4.360,P 〈 0.05;Z =-9.268,P 〈 0.05）.The degree of knee flexion of group CFNB at 3 and 6 months postoperatively was 92 （88-97）,103 （99-106）,while the degree of knee flexion of group PCIA was 89 （86-95）,100 （97-105）;the WOMAC scores of group CFNB at 3 and 6 months postoperatively was 21 （18-26）,18 （16-22）,while the scores of group PCIA was 24 （20-27）,21 （17-24）.WOMAC scores of group CFNB was lower compared with groupPCIA at 3（Z =-2.467,P =0.014）and 6（Z =-2.537,P =0.011） months postoperatively while the degree of knee flexion of group CFNB was higher（Z =-2.175,P =0.030;Z =-2.471,P =0.013）.Moreover,the frequency of bolus and frequency of rescue of group CFNB was 2.3 and 0.6,while the frequency of group PCIA was 2.6 and 1.1,the frequency of bolus and frequency of rescue were lower in group CFNB （t =-2.984,P =0.003;t =-3.213,P =0.002）.The incidence of adverse events such muscle weakness of low limbs,nausea and vomiting were similar in two groups （P 〉 0.05）.Conclusion CFNB can alleviate the postoperative pain after TKA with safety,help improving the shortmiddle-term functions of knee and quality of patients＇ lives.