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Chinese Journal of Reparative and Reconstructive Surgery logoLink to Chinese Journal of Reparative and Reconstructive Surgery
. 2026 Apr;40(4):540–547. [Article in Chinese] doi: 10.7507/1002-1892.202511055

布比卡因脂质体与“鸡尾酒”疗法在人工智能辅助下直接前方入路人工全髋关节置换术后镇痛疗效对比观察：一项前瞻性随机对照研究

Comparative observation of analgesic efficacy between liposomal bupivacaine and “cocktail” therapy following artificial intelligence-assisted direct anterior approach total hip arthroplasty: A prospective randomized controlled study

Yuyang ZHAI 1, Xun CAO 1, Shanbin ZHENG 1, Zhiyuan CHEN 1, Xinyi HOU 1, Tianchen ZHANG 1, Chao ZHANG 2, Tianwei XIA 2, Jirong SHEN 2,*
PMCID: PMC13096845  PMID: 41981425

Abstract

Objective

To compare the analgesic efficacy and safety of liposomal bupivacaine (LB) versus ropivacaine for surgical incision local anesthesia after artificial intelligence (AI)-assisted direct anterior approach (DAA) total hip arthroplasty (THA).

Methods

A prospective randomized controlled study was conducted. A total of 120 patients who underwent AI-assisted DAA-THA between March 2024 and January 2025 were enrolled and randomly assigned to the LB group (n=60) or the “cocktail” group (n=60). Patients in the LB group received an intraoperative injection of LB 266 mg (diluted to 100 mL) around the incision, whereas those in the “cocktail” group received a mixture of ropivacaine 200 mg, compound betamethasone 1 mL, and epinephrine 0.5 mg (diluted to 100 mL). Resting and active visual analogue scale (VAS) scores were recorded at 6, 12, 24, 36, 48, 60, and 72 hours and at 2 and 4 weeks postoperatively. Changes in Pain Catastrophizing Scale (PCS) score, Harris hip score, and hip flexion and abduction range of motion at 4 weeks postoperatively relative to preoperative values were assessed. In addition, operation time, incision length, total postoperative oral morphine consumption, time to first ambulation, length of hospital stay, and complications within 72 hours after surgery were recorded and compared between the two groups.

Results

There was no significant difference between the two groups in incision length, time to first ambulation, length of hospital stay, or total postoperative oral morphine consumption (P>0.05). Operation time was significantly longer in the LB group than in the “cocktail” group (P<0.05). All patients were followed up for 6 months postoperatively. Both resting and active VAS scores decreased over time in the two groups (P<0.05). Intergroup comparison showed that resting and active VAS scores at 60 and 72 hours postoperatively were significantly lower in the LB group than in the “cocktail” group (P<0.05), whereas no significant difference was observed at other time points (P>0.05). There was no significant difference between the two groups in the changes in PCS score, Harris Hip Score, or hip range of motion at 4 weeks postoperatively (P>0.05). In the LB group, nausea and vomiting occurred in 3 cases, significant blood glucose fluctuations in 2 cases, superficial incision infection in 1 case, and local hematoma in 1 case; the corresponding numbers in the “cocktail” group were 5, 4, 0, and 1 case, respectively. No significant difference was observed between the two groups in the incidence of these complications (P>0.05). No local allergic reactions, deep vein thrombosis, significant blood pressure fluctuations, deep incision infection, skin necrosis, or pulmonary embolism occurred in either group. At last follow-up, satisfaction rates for analgesic efficacy and hip function both exceeded 90% in the two groups, with no significant difference between groups (P>0.05).

Conclusion

In AI-assisted DAA-THA, local infiltration anesthesia with LB provides analgesic efficacy comparable to that of the “cocktail” therapy during the early postoperative period (within 48 hours). Although VAS scores were slightly lower in the LB group at 60-72 hours postoperatively, the difference was small and the clinical benefit was limited. No significant difference was observed between the two groups in opioid consumption, complication rates, PCS scores, or postoperative functional recovery. In the context of AI-assisted DAA-THA, the clinical advantage of LB over the conventional “cocktail” therapy appears limited.

Keywords: Liposomal bupivacaine, ropivacaine, postoperative analgesia, artificial intelligence, direct anterior approach, total hip arthroplasty

人工全髋关节置换术（total hip arthroplasty，THA）是目前治疗发育性髋关节发育不良、股骨头坏死、股骨颈骨折等终末期髋关节疾病的主流治疗方法[1-2]。随着围术期加速康复理念的推广，直接前方入路（direct anterior approach，DAA）作为一种微创入路逐渐受到关注[3-4]。DAA经阔筋膜张肌与股直肌间隙进入，避免切断肌肉或肌腱，可减少软组织损伤及炎症反应[5]。相较于后外侧入路（posterolateral approach，PLA），DAA能够有效避免股四头肌和耻骨肌损伤，减轻术后疼痛，降低并发症发生率，有利于患者预后[6]。但由于DAA切口较小、术中暴露有限，术中需对周围组织进行牵拉，导致术后短期内疼痛较为明显。疼痛正是患者术后抗拒功能锻炼、延迟下地负重行走的最主要原因之一，严重影响康复进程，延长住院时间，增加并发症风险[7-8]。因此，术后镇痛对于THA术后恢复及手术疗效至关重要。

患者的心理状况对术后疼痛及康复亦有显著影响。多项研究示消极心理因素为THA术后长期疼痛的危险因素[9-10]。疼痛灾难化量表（PCS）评分作为评估患者对疼痛的消极认知放大（如无助感、反复沉思和威胁夸大）的心理评估工具，其价值不仅在于预测术后疼痛，还与功能恢复、并发症感知及长期满意度密切相关，是优化THA加速康复流程的关键环节[11]。

局部浸润麻醉（local infiltration anesthesia，LIA）是目前THA常规术后镇痛方案[12]，通过将局部麻醉药物直接注射至手术切口周围、肌间隙、假体周围及皮下组织，作用于感觉神经末梢，阻断疼痛信号向中枢神经系统的传递[13]。目前临床常用的“鸡尾酒”疗法（罗哌卡因+得宝松+肾上腺素）可有效减轻THA术后24 h疼痛，但24 h后镇痛效果难以维持[14]。同时，肾上腺素的使用可能增加局部皮肤坏死风险，糖皮质激素则可能引起术后血糖波动，影响患者康复[15]。布比卡因脂质体（liposomal bupivacaine，LB）采用脂质体包裹水溶性布比卡因，每个囊泡由含布比卡因的含水腔室及隔开腔室的类脂双分子层构成，可延长镇痛时间至72 h[16-17]，目前已广泛应用于各类手术切口[18-20]。

尽管LB在关节置换领域的应用已有报道，但既往研究多集中于传统手术入路或未结合数字化技术。随着人工智能（artificial intelligence，AI）辅助术前规划的普及，DAA-THA的手术精准度进一步提高，软组织损伤进一步减少[21]。在此“精准微创”背景下，价格较高的LB是否仍较传统“鸡尾酒”疗法具有额外镇痛获益尚不明确。此外，现有研究多关注生理性疼痛评分，而忽视了镇痛方案对患者心理维度（如PCS评分）的影响。因此，本研究拟在AI辅助DAA-THA模式下，通过前瞻性随机对照研究，综合评估LB对术后中长期疼痛控制、阿片类药物消耗及PCS评分的影响，以期为优化加速康复路径下的精准镇痛方案提供循证医学证据。报告如下。

1. 临床资料

1.1. 一般资料

患者纳入标准：① 年龄≥18岁；② 具有THA手术指征；③ 均采用AI辅助系统进行术前规划与假体设计；④ 临床资料齐全；⑤ 无精神疾病或认知功能障碍。排除标准：① 对本研究使用的局部麻醉药物过敏；② 患有精神方面疾病无法配合治疗者；③ 既往或近期有阿片类药物服用史者；④ 不能耐受麻醉、手术者；⑤ 重度肝、肾功能不全者；⑥ 采用PLA行THA患者；⑦ 为了方便进行疼痛评分记录和统计，排除下午5点后结束手术的患者。

2024年3月—2025年1月共120例患者符合选择标准纳入研究，采用随机数字表法将患者分为LB组和“鸡尾酒”组，每组60例。两组患者性别、年龄、身体质量指数、手术侧别以及术前PCS评分、Harris评分、患髋屈曲及外展活动度等基线资料比较，差异均无统计学意义（P>0.05）。见表1。

表 1.

Comparison of the baseline data between groups (n=60)

两组患者基线资料比较（n=60）

基线资料
Baseline data		 LB组
LB group		 “鸡尾酒”组
“Cocktail” group		 统计量
Statistical value		 P 值
P value
性别（男/女，例） 26/34 31/29 χ2=0.835 0.361
年龄（x±s，岁） 57.13±13.78 58.64±14.18 t=0.557 0.579
身体质量指数（x±s，kg/m2） 24.19±3.68 24.68±3.55 t=0.715 0.476
手术侧别（左/右，例） 30/30 29/31 χ2=0.033 0.855
术前PCS评分（x±s） 25.5±2.2 26.6±2.9 t=1.623 0.107
术前患髋屈曲活动度（x±s，°） 84.67±14.41 84.83±14.20 t=0.064 0.949
术前患髋外展活动度（x±s，°） 16.58±5.33 17.17±4.90 t=0.624 0.534
术前Harris评分（x±s） 51.8±5.0 52.4±6.0 t=0.674 0.116
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1.2. 治疗方法

1.2.1. AI术前设计

患者入院后完善髋关节DR和CT、胸部CT、心电图、心脏超声、肺功能及三大常规、血生化等检查，排除手术禁忌后，采用AI术前规划系统（AIHIP系统）进行术前假体型号设计。见图1。

图 1.

AI preoperative design

AI术前设计

a、b. 髋臼左右径、上下径测量；c. 股骨颈干角测量；d. 股骨前倾角测量；e、f. 髋臼杯及内衬设计；g. 股骨柄及球头设计；h. 术后前倾角测量设计

a, b. Measurement of acetabular transverse and vertical diameters; c. Measurement of femoral neck-shaft angle; d. Measurement of femoral anteversion angle; e, f. Acetabular cup and liner design; g. Femoral stem and head design; h. Measurement of designed postoperative anteversion angle

图 1

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1.2.2. 手术方法

手术均由同一名经验丰富的高年资医生完成。患者于全身麻醉下取侧卧位，于髂前上棘远端向下方及侧方2～3 cm处，向腓骨小头方向作一长约10 cm切口。依次切开皮肤及皮下脂肪，显露阔筋膜张肌表面的阔筋膜，沿肌纤维方向切开阔筋膜，钝性分离缝匠肌、阔筋膜张肌之间的间隙，向深层显露旋股外侧动脉分支并予以结扎以减少出血。钝性分离线路并切除关节囊，暴露股骨颈。根据假体设计要求，沿转子间线截断股骨颈，取出股骨头；清理髋臼内盂唇、滑膜及骨赘，用髋臼锉从小到大依次磨锉髋臼，直至软骨下骨均匀渗血，植入相应型号的髋臼假体及内衬。显露股骨近端，逐级扩髓至合适位置后置入假体试模，复位髋关节，检查活动度及双下肢等长情况，确认稳定后取出试模，植入假体并复位。生理盐水冲洗术区并逐层缝合，敷料覆盖切口。

1.2.3. 镇痛方案

术中由1名不参与术后评分的医师采用多点注射法进行LIA，将镇痛药物注入后方关节囊、皮下肌肉层及脂肪层。LB组采用266 mg LB[22]，加入生理盐水稀释至100 mL；“鸡尾酒”组采用200 mg罗哌卡因+1 mL得宝松（含二丙酸倍他米松5 mg与倍他米松磷酸钠2 mg）+0.5 mg肾上腺素，加入生理盐水稀释至100 mL[23]。

术后依据髋关节术后加速康复专家共识[24-25]实施多模式疼痛管理，具体方案：① 基础措施：局部冰敷、患肢抬高以减轻炎症反应。② 非甾体抗炎药镇痛：口服给药包括双氯芬酸钠、塞来昔布、洛索洛芬钠等；静脉给药为术后常规静脉滴注氟比洛芬酯3 d。③ 阿片类药物阶梯镇痛：中度疼痛 ［疼痛视觉模拟评分（VAS）4～6分］ 联合口服阿片类药物，如曲马多或羟考酮；重度疼痛（VAS评分≥7分）采用肌肉注射吗啡或哌替啶。阿片类药物用量均换算为口服吗啡当量剂量进行统计，换算标准[26-27]：吗啡10 mg皮下注射相当于吗啡30 mg口服，羟考酮10 mg口服相当于吗啡20 mg口服，曲马多100 mg口服相当于吗啡10 mg口服。④ 其他管理措施：加强肌力锻炼，鼓励早期下地活动，并提供心理支持以减轻患者负担。

1.3. 疗效观察指标

记录并比较以下指标：两组患者术后6、12、24、36、48、60、72 h及2、4周的活动和静息痛VAS评分；术前及术后4周的PCS评分（包括沉思、夸大、无助感3个维度，总分越高提示疼痛灾难化水平越高），患髋屈曲、外展活动度，患髋Harris评分，以手术前后变化值进行统计分析；手术时间、切口长度、术后口服吗啡总用量、术后首次下地时间（助行器协助）、术后住院时间及术后72 h内呼吸抑制、嗜睡、恶心呕吐、头晕等麻醉不良反应发生情况。末次随访时，对患者术后镇痛效果和髋关节功能恢复情况进行自拟满意度调查（分为满意和不满意两个等级）。

1.4. 统计学方法

采用SPSS27.0统计软件进行分析。计量资料经Kolmogorov-Smirnov检验均符合正态分布，数据以均数±标准差表示，组间比较采用独立样本t检验；两组多个时间点比较采用重复测量方差分析，若不满足球形检验，采用Greenhouse-Geisser法进行校正，同一组别不同时间点比较采用Bonferroni法，同一时间点不同组别间比较采用多因素方差分析。计数资料以频数和构成比表示，组间比较采用四格表卡方检验或Fisher确切概率法；等级资料组间比较采用 Wilcoxon秩和检验。检验水准取双侧α=0.05。

2. 结果

两组患者切口长度、术后首次下地时间、术后住院时间、术后口服吗啡总用量比较差异均无统计学意义（P>0.05）；LB组手术时间长于“鸡尾酒”组，差异有统计学意义（P<0.05）。所有患者均获随访6个月。两组静息及活动VAS评分随时间推移均显著下降（P<0.05）；组间比较，术后60 h和72 h LB组静息和活动VAS评分均低于“鸡尾酒”组，差异有统计学意义（P<0.05），其余时间点组间差异均无统计学意义（P>0.05）。两组术后4周PCS评分变化值、Harris评分变化值，以及术后72 h患髋屈曲、外展活动度变化值比较差异亦无统计学意义（P>0.05）。LB组发生恶心呕吐3例、血糖大幅度波动2例、切口浅表感染1例、局部血肿1例，“鸡尾酒”组分别为5、4、0、1例，两组上述并发症发生率比较差异均无统计学意义（P>0.05）；两组术后72 h内均未出现呼吸抑制、嗜睡、头晕等其他麻醉相关不良反应，以及局部过敏反应、下肢深静脉血栓形成、血压大幅度波动、切口深部感染、皮肤坏死及肺栓塞等并发症。末次随访时，两组镇痛效果满意度及髋关节功能满意度均达90%以上，差异无统计学意义（P>0.05）。见表2、图2。

表 2.

Comparison of outcome indicators between groups (n=60)

两组患者结局指标比较（n=60）

结局指标
Outcome indicator		 LB组
LB group		 “鸡尾酒”组
“Cocktail” group		 效应值（95%CI）
Effect value (95%CI)		 P值
P value
手术时间（x±s，min） 115.68±30.17 105.13±18.04 MD=10.55（1.56，19.54） 0.022
切口长度（x±s，cm） 10.55±0.85 10.55±0.96 MD=0.00（−0.33，0.33） 1.000
术后住院时间（x±s，d） 6.40±1.22 6.28±1.25 MD=0.12（−0.33，0.56） 0.606
术后首次下地时间（x±s，h） 15.38±1.91 15.30±1.91 MD=0.08（−0.54，0.71） 0.793
术后口服吗啡总用量（x±s，mg） 4.04±3.26 4.57±3.41 MD=−0.53（−4.26，3.19） 0.763
术后4周Harris评分变化值（x±s） 33.50±3.82 32.28±5.25 MD=1.22（−0.44，2.88） 0.150
术后4周PCS评分变化值（x±s） −23.95±1.89 −24.53±2.42 MD=0.58（−0.20，1.37） 0.145
术后72 h患髋屈曲活动度变化值（x±s，°） 18.67±9.65 18.42±9.94 MD=0.25（−3.29，3.79） 0.889
术后72 h患髋外展活动度变化值（x±s，°） 12.33±3.74 12.08±3.94 MD=0.25（−1.14，1.64） 0.722
镇痛效果满意度（满意/不满意，例） 54/6 56/4 OR=0.64（0.17，2.41） 0.741
髋关节功能满意度（满意/不满意，例） 57/3 55/5 OR=1.73（0.39，7.58） 0.717
并发症 ［例（%）］
　恶心呕吐 3（5.00） 5（8.33） OR=1.73（0.39，7.58） 0.715
　血糖大幅波动 2（3.33） 4（6.67） OR=2.07（0.37，11.76） 0.679
　切口浅表感染 1（1.67） 0（0.00） — 1.000
　局部血肿 1（1.67） 1（1.67） OR=2.03（0.18，23.06） 1.000
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图 2.

The change trends of VAS scores after DAA-THA in both groups

两组患者术后VAS评分变化趋势

a. 静息VAS评分；b. 活动VAS评分

a. Resting VAS score; b. Active VAS score

图 2

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3. 讨论

DAA-THA是治疗各类髋关节疾病的常用手术方式，THA术后疼痛管理和功能恢复是确保患者快速康复的关键[28-29]。LIA被广泛应用于THA术后的疼痛控制[30-31]，研究表明使用LIA在THA术后显著降低了24 h内静息疼痛评分，并在术后康复及减少阿片类药物使用方面发挥出色[32]。LB作为新型局部麻醉药物，其核心特性在于超长效的镇痛效果。其通过脂质体纳米载体缓慢释放布比卡因，在切口周围形成药物储库，维持局部有效药物浓度长达72 h以上[33]。这种特性使其在术后疼痛管理中具有显著优势，尤其是在需要长时间镇痛的手术中，如腹部手术[34]、关节置换术[35-36]等。有研究表明，在理想情况下这一特性能够有效降低术后早期疼痛、减少阿片类药物需求，并可能促进患者康复[37-38]。Bowen等[39]通过随机对照试验表明，对于初次THA患者，使用LB较传统罗哌卡因能提供更好的镇痛效果。Ma等[40]在一项荟萃分析中表明，与传统布比卡因相比，LB在24 h内表现出更好的疼痛控制，并缩短了THA后的住院时间。但也有研究得出不同结论，LB在术后减少患者主观疼痛、降低阿片类药物使用及相关副作用方面的作用有限[41]；甚至有研究表明，LB在术后疼痛控制方面未展现更好效果，但增加了THA患者的住院成本[42]。

本研究中，LB组和“鸡尾酒”组在术后48 h内镇痛效果比较差异无统计学意义，这可能因为AI辅助下的DAA入路利用阔筋膜张肌与缝匠肌的自然间隙，避免了肌肉切断，本身即具有显著的“微创镇痛”效应，导致术后早期疼痛基线较低，从而掩盖了不同药物间的细微差异。其次，“鸡尾酒”配方中的罗哌卡因虽半衰期短，但高浓度局部浸润可在早期提供高强度的神经阻滞，配合得宝松的抗炎作用，足以覆盖术后早期的急性炎症高峰。此外，在术前AI设计下，DAA-THA较常规PLA-THA患者展示出更优的术后髋臼前倾角度，也更有利于术后早期疼痛及功能恢复[43]。LB组患者在中长期（术后60、72 h至数周内）的静息与活动VAS评分显著低于“鸡尾酒”组，显示出更持久的镇痛优势。这一结果与LB的缓释特性相符，LB独特的DepoFoam多囊泡脂质体传输技术能像“洋葱”一样层层释放布比卡因[44]，维持局部有效药物浓度长达72 h甚至更久。相比之下，传统“鸡尾酒”中的罗哌卡因通常在24～36 h后代谢殆尽，导致患者在出院前的活动期（术后72 h）可能出现镇痛空白期，而LB恰好填补了这一窗口，有利于患者的康复训练。

但尽管LB在延长镇痛时间方面表现突出，本研究并未观察到LB组在术后口服吗啡总用量、术后住院时间以及PCS评分水平上较“鸡尾酒”组存在显著差异。两组患者所需的补救性阿片类药物相当，出院时间未因镇痛方式不同而缩短，且患者对疼痛的灾难化认知程度在术后早期评估中也未因使用LB而降低。这可能与阿片类药物使用更多受术后即刻剧痛、个体化疼痛阈值及康复进程影响有关；住院时长则受多重因素（如功能恢复、并发症、社会支持）制约；而疼痛灾难化作为一种相对稳定的心理特质，短期镇痛方式的改变可能不足以对其产生显著影响。但仍有相关研究[45]表明，THA患者术前较高的PCS评分可能预示着术后更严重的疼痛和更长的恢复期。LB组手术时间长于“鸡尾酒”组，这可能因为LB的剂量需根据手术范围和患者个体差异调整，而传统“鸡尾酒”疗法的配方已标准化，操作流程更高效。部分研究[46]表明，LB的术中浸润操作可能比标准“鸡尾酒”疗法更耗时。

本研究中，术后4周内两组患者疼痛明显缓解，术侧髋关节功能指标（包括屈曲外展活动度、髋关节Harris评分）较术前明显改善，术后并发症发生率两组差异亦无统计学意义（P>0.05）。因此，尽管本研究发现LB组在术后60 h及72 h的VAS评分低于“鸡尾酒”组，差异有统计学意义，但需看到两组评分的绝对差值极小，这种细微的数值差异虽然满足了统计学显著性，但在临床实践中往往难以转化为患者主观可感知的实质性获益。既往研究[47]表明，THA术后VAS评分的最小临床重要差异需达到约1.9分（18.6 mm）才被认为具有临床意义。本研究中术后72 h时两组静息VAS评分差值仅为0.32分，远低于上述标准，这很好地解释了为何LB组虽然评分更低，却未能减少阿片类药物消耗或缩短住院时间。这也进一步提示，在AI辅助DAA入路本身已将疼痛基线降至较低水平的情况下，单纯依靠药物剂型改进所带来的镇痛获益可能已接近瓶颈。但LB能满足THA术后早期镇痛需求，发挥长期镇痛的优势[48]，且在多项研究[49-50]中仍展示出减少术后并发症发生、减少阿片类药物使用的潜力。因此，LB作为一种创新型局部麻醉剂，有望在更多手术中发挥重要作用，同时为减少阿片类药物依赖和优化镇痛方案提供新的解决方案。

本研究兼具方法学优势与局限性。在创新性方面，本研究聚焦于AI辅助DAA这一“精准微创”模式，最大限度排除了手术操作误差对镇痛评价的干扰；且引入PCS评分，弥补了单一VAS评分无法反映心理维度的缺陷，从而保证了研究结论的客观性与多维性。但本研究仍然存在以下不足：首先，样本量相对较小，可能限制了检测两组间较小但具有临床意义差异的统计效力。第二，由于两种局部浸润麻醉剂外观存在显著差异，实现完美的患者和评估者盲法存在挑战，这可能带来偏倚。第三，本研究未对是否合并基础病等混杂因素进行严格控制，这也可能带来偏倚。

综上述，在AI辅助DAA-THA术中使用LB进行LIA与“鸡尾酒”组相比，术后早期镇痛效果无明显差异，术后48 h后LB组镇痛效果优于“鸡尾酒”组，但对THA术后功能恢复影响较小，且术后并发症发生率、阿片类药物使用及PCS评分无明显差异。因此，虽两组均取得令人满意的镇痛结局，但与“鸡尾酒”组对比，使用LB进行LIA在本项研究中未见明显优势。

Funding Statement

国家自然科学基金面上项目（82274552）；江苏省研究生科研与实践创新计划项目（SJCX25_0875）；江苏省中医院重点病种创建项目（YZB2417）

National Natural Science Foundation of China (82274552); Jiangsu Provincial Graduate Research and Practice Innovation Program (SJCX25_0875); Jiangsu Provincial Hospital of Traditional Chinese Medicine Key Disease Creation Project (YZB2417)

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Articles from Chinese Journal of Reparative and Reconstructive Surgery are provided here courtesy of Sichuan University

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